The following data is part of a premarket notification filed by Stryker with the FDA for 780 Nm 1688 4k Camera System, 780 Nm L11 Led Light Source With Aim And Safelight Cable.
| Device ID | K214046 |
| 510k Number | K214046 |
| Device Name: | 780 Nm 1688 4K Camera System, 780 Nm L11 LED Light Source With AIM And Safelight Cable |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker 5900 Optical Court San Jose, CA 95138 |
| Contact | Michelle Hughes |
| Correspondent | Michelle Hughes Stryker 5900 Optical Court San Jose, CA 95138 |
| Product Code | GCJ |
| Subsequent Product Code | FCS |
| Subsequent Product Code | FCW |
| Subsequent Product Code | GWG |
| Subsequent Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-12-27 |
| Decision Date | 2022-05-25 |