EndoWrist;daVinci Si
Large Suture CUT Needle Driver
4manufacturers in China registered for this device type
55catalogue 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 | 2026-03-09 (version 41) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 6 |
| Sizes | Outer diameter 5 to 14 mm |
| Distribution end date | 2016-09-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 420275 | Outer Diameter 8 mm | In distribution |
| 420142 | Outer Diameter 8 mm | In distribution |
| 420207 | Outer Diameter 8 mm | In distribution |
| 420001 | Outer Diameter 8 mm | In distribution |
| 420007 | Outer Diameter 8 mm | In distribution |
| 420309 | Outer Diameter 8 mm | In distribution |
| 420327 | Outer Diameter 8 mm | In distribution |
| 420178 | Outer Diameter 8 mm | In distribution |
| 420036 | Outer Diameter 8 mm | In distribution |
| 420143 | Outer Diameter 5 mm | In distribution |
| 410299 | Outer Diameter 8 mm | In distribution |
| 410322 | Outer Diameter 8 mm | In distribution |
| 420177 | Outer Diameter 5 mm | In distribution |
| 420227 | Outer Diameter 8 mm | In distribution |
| 420296 | Outer Diameter 8 mm | In distribution |
| 420274 | Outer Diameter 5 mm | In distribution |
| 420049 | Outer Diameter 8 mm | In distribution |
| 420139 | Outer Diameter 5 mm | In distribution |
| 420343 | Outer Diameter 5 mm | In distribution |
| 420048 | Outer Diameter 8 mm | In distribution |
| 420192 | Outer Diameter 8 mm | In distribution |
| 420204 | Outer Diameter 8 mm | In distribution |
| 420033 | Outer Diameter 8 mm | In distribution |
| 420318 | Outer Diameter 8 mm | In distribution |
| 410298 | Outer Diameter 14 mm | In distribution |
| 420157 | Outer Diameter 8 mm | In distribution |
| 420172 | Outer Diameter 8 mm | In distribution |
| 420189 | Outer Diameter 8 mm | In distribution |
| 420278 | Outer Diameter 8 mm | In distribution |
| 420249 | Outer Diameter 8 mm | In distribution |
| 420194 | Outer Diameter 8 mm | In distribution |
| 420142 | Outer Diameter 5 mm | In distribution |
| 420230 | Outer Diameter 8 mm | In distribution |
| 420182 | Outer Diameter 12 mm | In distribution |
| 420190 | Outer Diameter 8 mm | In distribution |
| 420110 | Outer Diameter 8 mm | In distribution |
| 420183 | Outer Diameter 8 mm | In distribution |
| 420121 | Outer Diameter 8 mm | In distribution |
| 420205 | Outer Diameter 8 mm | In distribution |
| 420006 | Outer Diameter 8 mm | In distribution |
| 420117 | Outer Diameter 5 mm | In distribution |
| 420203 | Outer Diameter 8 mm | In distribution |
| 420093 | Outer Diameter 8 mm | In distribution |
| 420215 | Outer Diameter 8 mm | In distribution |
| 420181 | Outer Diameter 8 mm | In distribution |
| 420171 | Outer Diameter 8 mm | In distribution |
| 420246 | Outer Diameter 8 mm | In distribution |
| 420141 | Outer Diameter 5 mm | In distribution |
| 420145 | Outer Diameter 5 mm | In distribution |
| 420344 | Outer Diameter 8 mm | In distribution |
| 420184 | Outer Diameter 8 mm | In distribution |
| 420179 | Outer Diameter 8 mm | In distribution |
| 420146 | Outer Diameter 5 mm | In distribution |
| 420003 | Outer Diameter 8 mm | In distribution |
| 420170 | Outer Diameter 8 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Senhance | Asensus Surgical, Inc. | 147 |
| System, Surgical, Computer Controlled Instrument | Intuitive Surgical, Inc. | 106 |
| EndoWrist | Intuitive Surgical, Inc. | 68 |
| 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
7 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Intuitive Surgical, Inc. | UDI-DI | 2025-12-09 | Class II | Process control | Due to increased complaints for broken/frayed grip cables for reusable instruments. | 86904 |
| Intuitive Surgical, Inc. | UDI-DI | 2025-12-09 | Class II | Process control | Due to increased complaints for broken/frayed grip cables for reusable instruments. | 2370 |
| Intuitive Surgical, Inc. | UDI-DI | 2025-12-09 | Class II | Process control | Due to increased complaints for broken/frayed grip cables for reusable instruments. | 7819 |
| Intuitive Surgical, Inc. | UDI-DI | 2025-12-09 | Class II | Process control | Due to increased complaints for broken/frayed grip cables for reusable instruments. | 2660 |
| Intuitive Surgical, Inc. | UDI-DI | 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 |
| Intuitive Surgical, Inc. | UDI-DI | 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 |
| Intuitive Surgical, Inc. | UDI-DI | 2018-08-15 | Class II | Use error | Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extensio | 23,064 (S/Si) |
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 |
| 2025-12-15 | Class II | Packaging change control | Access Port System tray may develop cracks potentially resulting in a sterility breach. | 41,526 units |
| 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 |
| 2025-05-12 | 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 |
| 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.