510(k) K110639 ยท NAY System, Surgical, Computer Controlled Instrument
ENDOWRIST ONE VESSEL SEALER
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 28, 2011 |
| Received | Mar 4, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110639
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2015 | Intuitive Surgical, Inc. EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000
The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Terminated |
NAY | None listed |
| Jul 11, 2013 | Intuitive Surgical, Inc. da Vinci Instrument Control Box, model number ICB3000;
Manufactured by Intuitive Surgical, Sunnyvale, CA 94086.
Intuitive Surgical endoscopic Instrument Control System is intended to assist in the a Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.