510(k) K123463 ยท NAY System, Surgical, Computer Controlled Instrument
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 3, 2012 |
| Received | Nov 9, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123463
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2015 | Intuitive Surgical, Inc. da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System.
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Oct 16, 2014 | Intuitive Surgical, Inc. EndoWrist Stapler 45 instrument for the da Vinci Si System
Model Number: IS3000
Product Usage:
For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is inte Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.