The following data is part of a premarket notification filed by Stryker with the FDA for Adavanced Imaging Modality System (1688 4k Camera System With Advanced Imaging Modality, L11 Led Light Source With Adavanced Imaging Modality).
| Device ID | K202592 |
| 510k Number | K202592 |
| Device Name: | Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source With Adavanced Imaging Modality) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker 5900 Optical Ct San Jose, CA 95138 |
| Contact | Divya Sekar |
| Correspondent | Divya Sekar Stryker 5900 Optical Ct San Jose, CA 95138 |
| Product Code | GCJ |
| Subsequent Product Code | FCS |
| Subsequent Product Code | FCW |
| Subsequent Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-08 |
| Decision Date | 2020-10-08 |