510(k) K090993 ยท NAY System, Surgical, Computer Controlled Instrument
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 16, 2009 |
| Received | Apr 7, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090993
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2013 | Intuitive Surgical, Inc. Thyroidectomy Indication for the da Vinci Surgical Systems;
Product Usage:
da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including en Terminated |
NAY | None listed |
| May 29, 2013 | Intuitive Surgical, Inc. User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000.
Product Usage:
The user manual for Transoral Surgery (TORS) provided information to update and replace the Indic Terminated |
NAY | None listed |
| Aug 3, 2011 | Intuitive Surgical, Inc. Intuitive Surgical da Vinci Si Surgical System (IS3000);
Mfg by: Intuitive Surgical, Sunnyvale, CA 94086
Product Usage: Intended to assist in the accurate control of Intuitive Surgical Endoscopic E Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.