FDA device listing
10MM 0° LAPAROSCOPE, AC,10MM 30° AUTOCLAVABLE LAPAROSCOPE,10MM 30° LAPAROSCOPE, AC,10MM 45° AUTOCLAVABLE…
FDA device listing 1610195813 · STRYKER CORP.
Key facts
| Proprietary names | 10MM 0° LAPAROSCOPE, AC,10MM 30° AUTOCLAVABLE LAPAROSCOPE,10MM 30° LAPAROSCOPE, AC,10MM 45° AUTOCLAVABLE LAPAROSCOPE,10MM 45° LAPAROSCOPE, AC,2.7MM 0° AUTOCLAVABLE PEDIATRIC LAPAROSCOPE, 20CM,2.7MM 30° AUTOCLAVABLE PEDIATRIC LAPAROSCOPE, 20CM,5.0MM 0° AUTOCLAVABLE LAPAROSCOPE,5.0MM 30° AUTOCLAVABLE LAPAROSCOPE,5MM 0° FULL SCREEN AUTOCLAVABLE LAPAROSCOPE,5MM 0° LAPAROSCOPE, AC,5MM 30°… |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K910132 |
| Product codes | GCJ |
| Device names | GCJ - Laparoscope, General & Plastic Surgery |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | STRYKER EMEA Supply Chain Services, STRYKER ENDOSCOPY |
| Establishment registrations | 2936485, 3008837339 |
| FEI numbers | 2936485, 3008837339 |
| Establishment operations | Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database