510(k) K063220 ยท NAY System, Surgical, Computer Controlled Instrument
DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 1, 2006 |
| Received | Oct 24, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063220
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2012 | Intuitive Surgical, Inc. da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems.
Intuitive Surgical, Inc.
Sunnyvale, CA 94086.
The Intuitive Surgical Endoscopic instrument Control System is intended to Terminated |
NAY | None listed |
| Feb 22, 2008 | Intuitive Surgical, Inc. Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS1200 with Isolation Transformer (P/N: 952012) and Vision Cart (Model VS1000), Distributed and Manufactured by: Terminated |
NAY | None listed |
| Feb 22, 2008 | Intuitive Surgical, Inc. Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS2000 with Isolation Transformer (P/N: 952012) and Vision Cart (Model: VS2000), Distributed and Manufactured by Terminated |
NAY | None listed |
| Sep 26, 2007 | Intuitive Surgical, Inc. daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system. Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.