1788
The Stryker 1788 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field. The FDA summary describes transfer of optical…
The Stryker 1788 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field. The FDA summary describes transfer of optical images from the surgical site to the camera head through rigid or flexible endoscopes.
The system has a camera control unit, camera head with integral cable and coupler for attaching an endoscope. Its listed imaging modes include white light, near-infrared fluorescence and near-infrared transillumination.
Listed Item
1788 4K Pendulum Urology Camera Head with Integrated Coupler
Imaging Configuration
The summary lists indications including laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery when an endoscope is appropriate. The camera system is sensitive to visible and infrared spectra.
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | GCJ |
| Device type | Laparoscope, General & Plastic Surgery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K230605 |
| Record published | 2023-04-18 |
| Record revised | 2026-01-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1788010000 | In distribution | |
| 1788020122 | In distribution | |
| 1788310131 | In distribution | |
| 1788610122 | In distribution | |
| 1788710105 | In distribution | |
| 1788210105 | 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 |
|---|---|
| K232157 | 2023-08-18 |
| K230605 | 2023-03-31 |
| K230216 | 2023-02-23 |
| K222130 | 2022-08-19 |
| K221217 | 2022-06-17 |
| K214046 | 2022-05-25 |
| K220895 | 2022-04-22 |
| K212055 | 2021-12-16 |
| K212511 | 2021-11-04 |
| K210088 | 2021-04-13 |
| K210584 | 2021-03-18 |
| K202592 | 2020-10-08 |
| K201434 | 2020-07-28 |
| K200310 | 2020-03-06 |
| K192172 | 2019-09-09 |
| K181258 | 2018-11-05 |
| K182160 | 2018-11-05 |
| K930224 | 1994-06-30 |
| K934094 | 1994-02-18 |
| K910132 | 1991-02-21 |
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.