510(k) K214095 ยท NAY System, Surgical, Computer Controlled Instrument
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 15, 2022 |
| Received | Dec 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214095
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,LONG TIP FORCEPS,IS4000 REF 471048 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,CADIERE FORCEPS,IS4000 REF 471049 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,PROGRASP FORCEPS,IS4000 REF 471093 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,COBRA GRASPER,IS4000 REF 471190 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MEGA SUTURECUT ND,IS4000 REF 471309 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400 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.