510(k) K253556 ยท NAY System, Surgical, Computer Controlled Instrument
da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jan 16, 2026 |
| Received | Nov 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253556
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.