Laparoscope, General & Plastic Surgery
Camera Head Light Guide Adapter
46manufacturers in China registered for this device type
17catalogue numbers in this listing
17510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (15), Jiangsu (13), Zhejiang (7). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Shenzhen Jingxintai Houseware Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| MediConcepts Technology (Shenzhen) Company Limited | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Jiangsu Bana Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Comhuge Medical Wire AND Harness Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
Showing 12 of 46. All 46 manufacturers in China registered for Laparoscope, General & Plastic Surgery
Record
| Listed by | Intuitive Surgical, Inc., United States |
|---|---|
| FDA product code | GCJ |
| Device type | Laparoscope, General & Plastic Surgery |
| 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 | 2026-07-03 (version 16) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Peracetic Acid, Ethylene Oxide, Hydrogen Peroxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 5, box of 6, box of 10, case of 24, case of 16 |
| Sizes | Outer diameter 8 to 12 mm; lumen/inner diameter 5 to 12 mm; angle 0 to 30 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 371939 | Angle 30 ° | In distribution |
| 470035 | In distribution | |
| 311465 | Outer Diameter 12 mm | In distribution |
| 311485 | Angle 0 ° | In distribution |
| 470357 | Outer Diameter 8 mm | In distribution |
| 371938 | Angle 0 ° | In distribution |
| 470361 | Lumen/Inner Diameter 8 mm | In distribution |
| 470398 | Lumen/Inner Diameter 8 mm | In distribution |
| 470358 | Outer Diameter 8 mm | In distribution |
| 470500 | Lumen/Inner Diameter 5 mm | In distribution |
| 470066 | Angle 0 ° | In distribution |
| 371679 | Outer Diameter 8.5 mm | In distribution |
| 470399 | Lumen/Inner Diameter 12 mm | In distribution |
| 470042 | In distribution | |
| 470051 | In distribution | |
| 311486 | Angle 30 ° | In distribution |
| 420260 | Lumen/Inner Diameter 8.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elmed | Elmed, Inc. | 3,796 |
| Surgical Direct | Surgical Direct, Inc. | 2,319 |
| Novo Surgical | Novo Surgical, Inc. | 1,320 |
| Elmed Incorporated | Elmed, Inc. | 911 |
| Laparoscope, General & Plastic Surgery | Karl Storz GmbH & Co. KG | 774 |
| Snowden-Pencer | Steris Corporation | 693 |
| Millennium | Avalign Technologies, Inc. | 683 |
| Hermann Medizintechnik GmbH | Hermann Medizintechnik Gmbh | 615 |
| Clickline | Karl Storz GmbH & Co. KG | 582 |
| V. Mueller | Carefusion 2200, Inc. | 553 |
| Grasping forceps | Sopro-Comeg GmbH | 462 |
| Gimmi | Gimmi Gmbh | 387 |
Showing 12 of 1,584. All products under Laparoscope, General & Plastic Surgery
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261249 | 2026-07-14 |
| K253978 | 2026-02-24 |
| K251490 | 2025-07-02 |
| K241360 | 2024-08-05 |
| K231358 | 2023-07-05 |
| K191043 | 2019-06-06 |
| K181395 | 2018-07-27 |
| K153126 | 2015-12-09 |
| K152663 | 2015-10-16 |
| K133203 | 2014-05-09 |
| K133845 | 2014-02-19 |
| K101077 | 2011-02-04 |
| K080155 | 2008-03-06 |
| K013952 | 2002-02-28 |
| K001666 | 2000-08-24 |
| K990188 | 1999-04-01 |
| K965001 | 1997-07-31 |
Recalls
2 of these are Class II. 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 | Closed |
|---|---|---|---|---|---|
| 2014-11-21 | Class II | Labeling design | The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence. | 1532 | 2015-02-20 |
| 2014-11-21 | Class II | Labeling design | The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence. | 1532 total both devices | 2015-02-20 |
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.