FDA device listing
1688 AIM 4K CAMERA HEAD, C-MOUNT,1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER,1688 AIM 4K INLINE CAMERA HEAD…
FDA device listing 1395036384 · STRYKER CORP.
Key facts
| Proprietary names | 1688 AIM 4K CAMERA HEAD, C-MOUNT,1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER,1688 AIM 4K INLINE CAMERA HEAD, C-MOUNT,1688 Camera Control Unit,1688 Pendulum Camera Head with Coupler,AIM 4K Coupler, 20mm, C-Mount,AIM HD LAPAROSCOPE, AUTOCLAVABLE, 10MM x 0, 33CM,AIM HD LAPAROSCOPE, AUTOCLAVABLE, 10MM x 30, 33CM,AIM HD LAPAROSCOPE, AUTOCLAVABLE, 5.4MM x 0, 30CM,AIM HD LAPAROSCOPE, AUTOCLAVABLE… |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K210088 |
| Product codes | FCS, FCW, GCJ, OWN |
| Device names | FCS - Light, Catheter, Fiberoptic, Glass, Ureteral, FCW - Light Source, Fiberoptic, Routine, GCJ - Laparoscope, General & Plastic Surgery, OWN - Confocal Optical Imaging |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500, 876.4020 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | STRYKER ENDOSCOPY |
| Establishment registrations | 2936485 |
| FEI numbers | 2936485 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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