The following data is part of a premarket notification filed by Stryker with the FDA for 1688 4k Camera Control Unit With Advanced Imaging Modality (1688010000), Aim 4k Autoclave Camera Head, C-mount (1688410105), Aim 4k Autoclave Coupler, C-mount (1688410110).
| Device ID | K212511 |
| 510k Number | K212511 |
| Device Name: | 1688 4K Camera Control Unit With Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-10 |
| Decision Date | 2021-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327562552 | K212511 | 000 |
| 07613327562545 | K212511 | 000 |