510(k) K152448 ยท NAY System, Surgical, Computer Controlled Instrument
da Vinci Single-Site Instrument and Accessories
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 9, 2016 |
| Received | Aug 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152448
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 28, 2023 | Intuitive Surgical, Inc. Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm Open, Classified |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.