510(k) K113706 ยท NAY System, Surgical, Computer Controlled Instrument
ENDOWRIST STAPLER SYSTEM
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 17, 2012 |
| Received | Dec 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113706
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2014 | Intuitive Surgical, Inc. EndoWrist Stapler System User Manual Addendum and Wall Chart;
The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3 Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.