510(k) K101743 ยท NAY System, Surgical, Computer Controlled Instrument
5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 4, 2011 |
| Received | Jun 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101743
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2013 | Intuitive Surgical, Inc. da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems.
Used to establish a port of entry for Intuitive Surgical EndoWrist instruments, Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.