510(k) K093217 ยท NAY System, Surgical, Computer Controlled Instrument
5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jan 21, 2010 |
| Received | Oct 13, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093217
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2019 | Intuitive Surgical, Inc. daVinci Harmonic ACE Curved Shears Open, Classified |
NAY | None listed |
| Feb 13, 2015 | Intuitive Surgical, Inc. HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System.
Intended for soft tissue incisions when bleeding control and minimal thermal injury a Terminated |
NAY | None listed |
| Feb 13, 2015 | Intuitive Surgical, Inc. HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000.
Intended for soft tissue incisions when bleeding control and minima Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.