510(k) K162411 · NAY System, Surgical, Computer Controlled Instrument
da Vinci Xi 12 8 mm Reducer
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 21, 2016 |
| Received | Aug 29, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162411
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2021 | Intuitive Surgical, Inc. da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11 Open, Classified |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.