510(k) K242163 ยท OWN Confocal Optical Imaging
SmartSurgN Visualization System
| Applicant | SmartsurgN, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Apr 20, 2026 |
| Received | Jul 24, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242163
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.