FDA device listing
10mm Articulating Laparoscope,5mm Articulating Laparoscope,5mm Bariatric Articulating Laparoscope,Bariatric Articulating…
FDA device listing 1354992126 · STRYKER CORP.
Key facts
| Proprietary names | 10mm Articulating Laparoscope,5mm Articulating Laparoscope,5mm Bariatric Articulating Laparoscope,Bariatric Articulating Laparoscope Sterilization Tray,Flexible Control Unit,LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES),Video Ureteroscope |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K082451 |
| Product codes | HET |
| Device names | HET - Laparoscope, Gynecologic (And Accessories) |
| Device class | Class II |
| Classification regulations (21 CFR) | 884.1720 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | STRYKER EMEA Supply Chain Services, STRYKER ENDOSCOPY |
| Establishment registrations | 2936485, 3008837339 |
| FEI numbers | 2936485, 3008837339 |
| Establishment operations | Foreign Exporter, Manufacturer |
| 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