510(k) K140189 ยท NAY System, Surgical, Computer Controlled Instrument
ENDOWRIST VESSEL SEALER
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 5, 2014 |
| Received | Jan 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140189
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2015 | Intuitive Surgical, Inc. EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000.
The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.