510(k) K150837 ยท NAY System, Surgical, Computer Controlled Instrument
IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 29, 2015 |
| Received | Mar 30, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150837
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,HORIZON SMALL CLIP APPLIER,IS4000 REF 470401 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400 Open, Classified |
NAY | None listed |
| Jul 1, 2022 | Intuitive Surgical, Inc. Da Vinci X/Xi Large Clip Applier, Model 470230
Da Vinci X/Xi Medium-Large Clip Applier, Model 470327
Da Vinci X/Xi Small Clip Applier, Model 47401 Open, Classified |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.