510(k) K180351 ยท NAY System, Surgical, Computer Controlled Instrument
EndoWrist Mercury Bipolar Grasper
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 7, 2018 |
| Received | Feb 8, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180351
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,FORCE BIPOLAR,IS4000 REF 470405 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,FORCE BIPOLAR,IS4000 REF 471405 Open, Classified |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.