510(k) K183224 ยท NAY System, Surgical, Computer Controlled Instrument
SureForm 45, SureForm 45 Reloads
| Applicant | Intuitive Surgical, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jan 18, 2019 |
| Received | Nov 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183224
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2022 | Intuitive Surgical, Inc. da Vinici X da Vinci Xi Sureform 45 REF 480445
da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545
da Vinici X da Vinci Xi Sureform 60 REF 480460 Open, Classified |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.