510(k) K080291 ยท NAY System, Surgical, Computer Controlled Instrument
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 19, 2008 |
| Received | Feb 4, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080291
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2015 | Intuitive Surgical, Inc. Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000);
Part number 420187-05.
The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used wit Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.