510(k) K182160 ยท GCJ Laparoscope, General & Plastic Surgery
1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM
| Applicant | Stryker, San Jose CA, US |
| Decision | Substantially Equivalent, Nov 5, 2018 |
| Received | Aug 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182160
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2022 | Stryker Corporation 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/s Open, Classified |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.