510(k) K150284 ยท NAY System, Surgical, Computer Controlled Instrument
IS4000 da Vinci EndoWrist Instruments
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 15, 2015 |
| Received | Feb 5, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150284
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM, ROUND TIP SCISSORS, IS4000 REF 470007 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,DEBAKEY FORCEPS,IS4000 REF 470036 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,CADIERE FORCEPS,IS4000 REF 470049 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MEGA NEEDLE DRIVER,IS4000 REF 470194 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 470296 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,COBRA GRASPER,IS4000 REF 471190 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 Open, Classified |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.