510(k) K130266 ยท NAY System, Surgical, Computer Controlled Instrument
ENDOWRIST ONE VESSEL SEALER
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 29, 2013 |
| Received | Feb 4, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130266
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2014 | Intuitive Surgical, Inc. EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000.
The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surg Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.