System, Surgical, Computer Controlled Instrument
3DHD Camera Head AND Cable, Panasonic HD, Japan
4manufacturers in China registered for this device type
106catalogue numbers in this listing
146510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Agibot Medtech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
| Zhuhai Dipu Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 3 |
Record
| Listed by | Intuitive Surgical, Inc., United States |
|---|---|
| FDA product code | NAY |
| Device type | System, Surgical, Computer Controlled Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-07-08 |
| Record revised | 2025-05-08 (version 30) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 10, box of 6, case, box of 5, case of 6, case of 4 |
| Sizes | Outer diameter 2.745 to 45 mm; lumen/inner diameter 5 to 45 mm; length 19 to 20 ft; angle 0 to 30 °; length 100 mm; length 7.4 m; length 6 in |
| Distribution end date | 2017-06-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 470057 | Angle 30 ° | In distribution | |
| 470056 | Outer Diameter 8 mm | In distribution | |
| 371715 | Length 20 ft | In distribution | |
| 380980 | In distribution | ||
| 380982 | In distribution | ||
| 420009 | Outer Diameter 8 mm | In distribution | |
| 311613 | Outer Diameter 45 mm | In distribution | |
| 311464 | Outer Diameter 12 mm | In distribution | |
| 371454 | Lumen/Inner Diameter 12 mm | In distribution | |
| 430020 | In distribution | ||
| 420020 | Lumen/Inner Diameter 12 mm | In distribution | |
| 371870 | Length 20 ft | In distribution | |
| 340084 | In distribution | ||
| 710276 | Outer Diameter 8 mm | 3 | In distribution |
| 470376 | Outer Diameter 12 mm | In distribution | |
| 371716 | Length 20 ft | In distribution | |
| 420011 | Lumen/Inner Diameter 5 mm | In distribution | |
| 470390 | Outer Diameter 5 mm | In distribution | |
| 420012 | Outer Diameter 5 mm | In distribution | |
| 400160 | Outer Diameter 5 mm | In distribution | |
| 371868 | Length 19 ft | In distribution | |
| 380642 | In distribution | ||
| 380727 | In distribution | ||
| 370890 | Angle 0 ° | In distribution | |
| 370793 | In distribution | ||
| 430075 | In distribution | ||
| 371718 | Length 20 ft | In distribution | |
| 470015 | In distribution | ||
| 380628 | In distribution | ||
| 400180 | Outer Diameter 8 mm | In distribution | |
| 420013 | Outer Diameter 5 mm | In distribution | |
| 430073 | In distribution | ||
| 470008 | Outer Diameter 8 mm | In distribution | |
| 400263 | Lumen/Inner Diameter 8.5 mm | In distribution | |
| 470397 | Outer Diameter 8 mm | 3 | In distribution |
| 710276 | Outer Diameter 8 mm | In distribution | |
| 470062 | Lumen/Inner Diameter 8 mm | In distribution | |
| 470002 | Lumen/Inner Diameter 8 mm | In distribution | |
| 370534 | Outer Diameter 2.745 mm | In distribution | |
| 430035 | In distribution | ||
| 400077 | Lumen/Inner Diameter 8 mm | In distribution | |
| 399201 | In distribution | ||
| 470004 | Lumen/Inner Diameter 8 mm | In distribution | |
| 420255 | Lumen/Inner Diameter 8 mm | In distribution | |
| 400158 | Outer Diameter 5 mm | 20 | In distribution |
| 371521 | Lumen/Inner Diameter 12 mm | In distribution | |
| 380989 | In distribution | ||
| 470395 | Outer Diameter 12 mm | In distribution | |
| 432701 | In distribution | ||
| 430016 | Outer Diameter 25 mm | In distribution | |
| 371499 | Length 20 ft | In distribution | |
| 430036 | Length 100 mm | In distribution | |
| 370539 | Lumen/Inner Diameter 45 mm | In distribution | |
| 400156 | Outer Diameter 5 mm | In distribution | |
| 381175 | Length 7.4 m | In distribution | |
| 951021 | In distribution | ||
| 470067 | Outer Diameter 8 mm | In distribution | |
| 470389 | Lumen/Inner Diameter 12 mm | In distribution | |
| 470375 | Lumen/Inner Diameter 12 mm | In distribution | |
| 371500 | Length 20 ft | In distribution | |
| 470027 | Angle 30 ° | In distribution | |
| 372011 | Outer Diameter 8.5 mm | In distribution | |
| 420019 | Outer Diameter 8 mm | In distribution | |
| 371512 | Lumen/Inner Diameter 12 mm | In distribution | |
| 371871 | Length 20 ft | In distribution | |
| 340250 | In distribution | ||
| 399202 | In distribution | ||
| 342562 | Outer Diameter 8 mm | In distribution | |
| 420254 | Lumen/Inner Diameter 8 mm | In distribution | |
| 470064 | Lumen/Inner Diameter 8 mm | In distribution | |
| 420004 | Lumen/Inner Diameter 8 mm | In distribution | |
| 370678 | Lumen/Inner Diameter 12 mm | In distribution | |
| 470396 | Outer Diameter 12 mm | In distribution | |
| 371528 | Lumen/Inner Diameter 12 mm | In distribution | |
| 400272 | Outer Diameter 5 mm | In distribution | |
| 370538 | Lumen/Inner Diameter 45 mm | In distribution | |
| 380981 | In distribution | ||
| 371717 | Length 20 ft | In distribution | |
| 313035 | In distribution | ||
| 420262 | Lumen/Inner Diameter 5 mm | In distribution | |
| 420021 | Outer Diameter 12 mm | In distribution | |
| 470009 | Outer Diameter 8 mm | In distribution | |
| 371484 | Length 20 ft | In distribution | |
| 430013 | In distribution | ||
| 371498 | Length 20 ft | In distribution | |
| 380979 | In distribution | ||
| 400152 | Angle 15 ° | 20 | In distribution |
| 370891 | Angle 30 ° | In distribution | |
| 370810 | In distribution | ||
| 470319 | Lumen/Inner Diameter 8 mm | In distribution | |
| 400160 | Outer Diameter 5 mm | In distribution | |
| 420008 | Outer Diameter 8 mm | In distribution | |
| 470026 | Angle 0 ° | In distribution | |
| 480275 | Outer Diameter 8 mm | In distribution | |
| 372600 | Length 6 in | In distribution | |
| 430012 | 2 | In distribution | |
| 470380 | Lumen/Inner Diameter 12 mm | In distribution | |
| 400156 | Outer Diameter 5 mm | In distribution | |
| 951026 | In distribution | ||
| 420002 | Lumen/Inner Diameter 8 mm | In distribution | |
| 371483 | Length 20 ft | Withdrawn | |
| 370387 | Outer Diameter 8 mm | Withdrawn | |
| 370386 | Outer Diameter 8 mm | Withdrawn | |
| 420010 | Outer Diameter 8 mm | Withdrawn | |
| 420319 | Lumen/Inner Diameter 8 mm | Withdrawn | |
| 420005 | Outer Diameter 8 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Senhance | Asensus Surgical, Inc. | 147 |
| EndoWrist | Intuitive Surgical, Inc. | 68 |
| EndoWrist;daVinci Si | Intuitive Surgical, Inc. | 55 |
| EndoWrist SP | Intuitive Surgical, Inc. | 22 |
| Force Feedback | Intuitive Surgical, Inc. | 20 |
| Single-Site | Intuitive Surgical, Inc. | 14 |
| daVinci Si | Intuitive Surgical, Inc. | 9 |
| Single-Site; daVinci Si | Intuitive Surgical, Inc. | 8 |
| SureForm | Intuitive Surgical, Inc. | 6 |
| daVinci Xi | Intuitive Surgical, Inc. | 6 |
| daVinci 5 | Intuitive Surgical, Inc. | 5 |
| Senhance Ultrasonic | Asensus Surgical, Inc. | 5 |
Showing 12 of 62. All products under System, Surgical, Computer Controlled Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261824 | 2026-07-31 |
| K260695 | 2026-05-22 |
| K253986 | 2026-03-11 |
| K253556 | 2026-01-16 |
| K251739 | 2026-01-16 |
| K252675 | 2025-12-15 |
| K252069 | 2025-12-02 |
| K251426 | 2025-10-03 |
| K251817 | 2025-09-10 |
| K251227 | 2025-09-08 |
| K251324 | 2025-08-29 |
| K252350 | 2025-08-28 |
| K250442 | 2025-07-29 |
| K251213 | 2025-07-23 |
| K251202 | 2025-07-16 |
| K250674 | 2025-06-13 |
| K240852 | 2025-06-11 |
| K250786 | 2025-05-13 |
| K243714 | 2025-04-24 |
| K242427 | 2025-04-01 |
| K243582 | 2025-02-28 |
| K243641 | 2024-12-16 |
| K242318 | 2024-11-26 |
| K241814 | 2024-11-18 |
| K241638 | 2024-09-10 |
| K240502 | 2024-07-08 |
| K241284 | 2024-07-03 |
| K232773 | 2024-06-04 |
| K240723 | 2024-05-24 |
| K232610 | 2024-03-14 |
| K231798 | 2023-11-08 |
| K231224 | 2023-05-12 |
| K230033 | 2023-04-05 |
| K222839 | 2023-03-16 |
| K223080 | 2022-11-22 |
| K222827 | 2022-10-20 |
| K214095 | 2022-08-15 |
| K213710 | 2022-02-17 |
| K220023 | 2022-01-31 |
| K211997 | 2021-12-10 |
| K212101 | 2021-11-23 |
| K212747 | 2021-09-29 |
| K211784 | 2021-08-06 |
| K211316 | 2021-07-23 |
| K211595 | 2021-06-23 |
| K210918 | 2021-04-26 |
| K203632 | 2021-02-10 |
| K202968 | 2020-12-22 |
| K202834 | 2020-12-10 |
| K202571 | 2020-11-12 |
| K192717 | 2020-09-28 |
| K192803 | 2020-04-29 |
| K183086 | 2020-03-31 |
| K191529 | 2020-02-06 |
| K191280 | 2019-11-14 |
| K191736 | 2019-07-26 |
| K190999 | 2019-07-12 |
| K182371 | 2019-03-14 |
| K183224 | 2019-01-18 |
| K183107 | 2018-12-11 |
| K182140 | 2018-10-24 |
| K180351 | 2018-08-07 |
| K173585 | 2018-07-19 |
| K173721 | 2018-07-05 |
| K173415 | 2018-05-31 |
| K173906 | 2018-05-31 |
| K173337 | 2018-04-26 |
| K173842 | 2018-04-23 |
| K180033 | 2018-04-06 |
| K172643 | 2018-01-31 |
| K170641 | 2017-09-21 |
| K170879 | 2017-09-21 |
| K171632 | 2017-09-19 |
| K170875 | 2017-09-12 |
| K170645 | 2017-09-11 |
| K170644 | 2017-09-11 |
| K171699 | 2017-07-28 |
| K170713 | 2017-06-13 |
| K171426 | 2017-06-13 |
| K171388 | 2017-05-31 |
| K171294 | 2017-05-26 |
| K170865 | 2017-04-21 |
| K170508 | 2017-03-10 |
| K162973 | 2017-02-06 |
| K161178 | 2017-01-19 |
| K162411 | 2016-09-21 |
| K153276 | 2016-08-07 |
| K161271 | 2016-07-11 |
| K152892 | 2016-04-29 |
| K152578 | 2016-03-30 |
| K152448 | 2016-03-09 |
| K152421 | 2016-03-04 |
| K151794 | 2016-01-15 |
| K150284 | 2015-05-15 |
| K150837 | 2015-04-29 |
| K143132 | 2015-04-02 |
| K142683 | 2014-12-10 |
| K143217 | 2014-12-03 |
| K141075 | 2014-09-26 |
| K123329 | 2014-09-17 |
| K141077 | 2014-08-12 |
| K140553 | 2014-07-25 |
| K140189 | 2014-06-05 |
| K131962 | 2014-04-17 |
| K131861 | 2014-03-28 |
| K130266 | 2013-08-29 |
| K122532 | 2013-07-30 |
| K130726 | 2013-06-07 |
| K123840 | 2013-02-14 |
| K123463 | 2012-12-03 |
| K121921 | 2012-10-25 |
| K113706 | 2012-10-17 |
| K120215 | 2012-04-30 |
| K110639 | 2011-12-28 |
| K112208 | 2011-12-08 |
| K112263 | 2011-10-07 |
| K112584 | 2011-09-29 |
| K110451 | 2011-08-26 |
| K101581 | 2011-04-08 |
| K101743 | 2011-02-04 |
| K093217 | 2010-01-21 |
| K090993 | 2009-12-16 |
| K082497 | 2009-05-07 |
| K081137 | 2009-02-18 |
| K081207 | 2008-12-19 |
| K080291 | 2008-03-19 |
| K070947 | 2008-02-14 |
| K072627 | 2008-02-07 |
| K063220 | 2006-12-01 |
| K061260 | 2006-05-18 |
| K060391 | 2006-04-10 |
| K050802 | 2005-06-29 |
| K050369 | 2005-04-29 |
| K043288 | 2005-03-03 |
| K050005 | 2005-01-25 |
| K043153 | 2004-12-15 |
| K042855 | 2004-11-12 |
| K040237 | 2004-07-07 |
| K040948 | 2004-05-05 |
| K022574 | 2002-11-12 |
| K021036 | 2002-06-26 |
| K012833 | 2001-11-16 |
| K011281 | 2001-07-24 |
| K011002 | 2001-05-30 |
| K002489 | 2001-03-02 |
| K990144 | 2000-07-11 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Intuitive Surgical, Inc. | UDI-DI | 2025-12-15 | Class II | Packaging change control | Access Port System tray may develop cracks potentially resulting in a sterility breach. | 41,526 units | |
| Intuitive Surgical, Inc. | UDI-DI | 2025-05-12 | Class II | Process control | Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or | 11113 | |
| Intuitive Surgical, Inc. | UDI-DI | 2021-09-21 | Class II | Labeling Change Control | Incorrect expiration date on its package labeling (shipper box and inner carton label). | 1,740 drapes (87 bobes) | 2024-01-25 |
| Intuitive Surgical, Inc. | UDI-DI | 2018-10-25 | Class II | Device Design | The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier. | 1818 pouches | 2024-04-05 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-04-24 | Class II | Device Design | Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope. | 1357 systems |
| 2026-04-22 | Class II | Process control | Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if | 454 |
| 2026-04-02 | Class II | Nonconforming Material/Component | Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking. | 2781 |
| 2026-03-11 | Class I | Under Investigation by firm | Reloads for curved-tipped stapler may potentially produce an incomplete staple line. | |
| 2025-12-30 | Class II | Process change control | Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, | 47 |
| 2025-12-09 | Class II | Process control | Due to increased complaints for broken/frayed grip cables for reusable instruments. | 86904 |
| 2025-12-09 | Class II | Process change control | Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments | 2095 instruments |
| 2025-12-09 | Class II | Process control | Due to increased complaints for broken/frayed grip cables for reusable instruments. | 7819 |
| 2025-12-09 | Class II | Process control | Due to increased complaints for broken/frayed grip cables for reusable instruments. | 2660 |
| 2025-12-09 | Class II | Process change control | Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments | 6152 instruments |
| 2025-12-09 | Class II | Process control | Due to increased complaints for broken/frayed grip cables for reusable instruments. | 2370 |
| 2025-11-17 | Class II | Software Design Change | An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor. | 12 |
| 2025-11-07 | Class II | Process control | Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that | 219 |
| 2025-02-26 | Class II | Device Design | Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed | 439 units |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 8,578 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 11,162 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 141 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 1,111 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 46,759 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 783 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 3,869 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 784 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 7,132 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 29,559 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 88,840 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 1,562 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12,340 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 14,507 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 30,316 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 5,576 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 178 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 738 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 99,249 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 9,303 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 147,006 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 1,739 |
| 2024-12-19 | Class II | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 68,458 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.