FDA device listing
CHROMOVISION HD Cameras,P59109 StrykeCam 4K, In-Light Camera,Strykecam 2 In-Light Camera,Strykecam for F-Gen,Strykecam…
FDA device listing 1266757389 · STRYKER CORP.
Key facts
| Proprietary names | CHROMOVISION HD Cameras,P59109 StrykeCam 4K, In-Light Camera,Strykecam 2 In-Light Camera,Strykecam for F-Gen,Strykecam for Visum LED,Strykecam HD for F-Gen,Strykecam HD In-Light Camera |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | KQM |
| Device names | KQM - Camera, Surgical And Accessories |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4160 |
| Review panels | General & Plastic Surgery |
| Registered establishments | BERCHTOLD GMBH & CO. KG, STRYKER Communications, Inc., STRYKER ENDOSCOPY |
| Establishment registrations | 2031963, 2936485, 8010153 |
| FEI numbers | 2936485, 3002975342, 3006125657 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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