510(k) K251213 ยท NAY System, Surgical, Computer Controlled Instrument
Da Vinci Surgical System (IS5000)
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 23, 2025 |
| Received | Apr 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251213
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.