The following data is part of a premarket notification filed by Stryker with the FDA for 1688 4k Camera System, L11 Led Light Source With Aim, Aim Safelight Cable, Precision S 4k Sinuscopes.
| Device ID | K211202 |
| 510k Number | K211202 |
| Device Name: | 1688 4K Camera System, L11 LED Light Source With AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes |
| Classification | Endoscope, Neurological |
| Applicant | Stryker 5900 Optical Court San Jose, CA 95138 |
| Contact | Jessie Duong |
| Correspondent | Jessie Duong Stryker 5900 Optical Court San Jose, CA 95138 |
| Product Code | GWG |
| Subsequent Product Code | FCS |
| Subsequent Product Code | FCW |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | OWN |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-04-22 |
| Decision Date | 2021-08-06 |