The following data is part of a premarket notification filed by Stryker with the FDA for 1688 4k Camera System With Advanced Imaging Modality.
| Device ID | K222130 |
| 510k Number | K222130 |
| Device Name: | 1688 4K Camera System With Advanced Imaging Modality |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker 5900 Optical Court San Jose, CA 95138 |
| Contact | Marlene Fraga |
| Correspondent | Marlene Fraga Stryker 5900 Optical Court San Jose, CA 95138 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-18 |
| Decision Date | 2022-08-19 |