510(k) K152421 ยท NAY System, Surgical, Computer Controlled Instrument
IS4000 Stapler 30 Instrument and Stapler 30 Reloads
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 4, 2016 |
| Received | Aug 26, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152421
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2016 | Intuitive Surgical, Inc. CURVED-TIP STAPLER 30,IS4000; Model number 470530;
General and Plastic Surgery:
The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the Terminated |
NAY | None listed |
| Aug 5, 2016 | Intuitive Surgical, Inc. STAPLER 30, IS4000, model number 470430;
Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Terminated |
NAY | None listed |
| Aug 5, 2016 | Intuitive Surgical, Inc. CURVED-TIP STAPLER 30,IS4000, model number 470530;
Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the d Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.