510(k) K070947 ยท NAY System, Surgical, Computer Controlled Instrument
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 14, 2008 |
| Received | Apr 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070947
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2008 | Intuitive Surgical, Inc. INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02; Product is manufactured and distributed by Intuitive Surgical, Inc. Sunnyvale Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.