SPY
The SPY Laparoscope is a tubular optical instrument in Stryker’s rigid endoscope portfolio. The filing describes it for endoscopic white-light and near-infrared illumination and imaging…
The SPY Laparoscope is a tubular optical instrument in Stryker’s rigid endoscope portfolio. The filing describes it for endoscopic white-light and near-infrared illumination and imaging during laparoscopic procedures.
Its indicated use covers gynecological and general procedures considered appropriate for adults or pediatric patients aged one month or older, when the laparoscope dimensions suit the patient’s size and anatomy. The filing identifies imaging with white light and near-infrared modes as its intended purpose.
Imaging Use
The FDA summary specifies age and procedure categories and limits use to cases in which the laparoscope dimensions suit the patient. Its stated role is white-light and near-infrared illumination and imaging.
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) | K221217 |
| Record published | 2022-08-24 |
| Record revised | 2022-09-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
| Sizes | Length 30 to 45 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0502948030 | Degree: 30.0 Degree | In distribution |
| 0502948045 | Degree: 45.0 Degree | In distribution |
| 0502538030 | Diameter: 5.4 Millimeter | In distribution |
| 0502538045 | Diameter: 5.4 Millimeter | In distribution |
| 0502548045 | Length 45.0 cm | In distribution |
| 0502548010 | Diameter: 5.4 Millimeter | In distribution |
| 0502938010 | Diameter: 10.0 Millimeter | In distribution |
| 0502548030 | Degree: 30.0 Degree | In distribution |
| 0502938030 | Degree: 30.0 Degree | In distribution |
| 0502938045 | Degree: 45.0 Degree | In distribution |
| 0502538010 | Degree: 0.0 Degree | In distribution |
| 0502948010 | Degree: 0.0 Degree | 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.