510(k) K122532 ยท NAY System, Surgical, Computer Controlled Instrument
DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Unknown, Jul 30, 2013 |
| Received | Aug 20, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122532
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2015 | Intuitive Surgical, Inc. Maryland Dissector; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428050-12, 428050-13 and 428050-14;
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used Terminated |
NAY | None listed |
| Sep 10, 2015 | Intuitive Surgical, Inc. Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428055-12, 428055-13.
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vin Terminated |
NAY | None listed |
| Sep 10, 2015 | Intuitive Surgical, Inc. Needle Driver; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428056-12, 428056-13.
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Terminated |
NAY | None listed |
| Sep 10, 2015 | Intuitive Surgical, Inc. Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428080-04, 428080-05.
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with t Terminated |
NAY | None listed |
| Sep 10, 2015 | Intuitive Surgical, Inc. Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428088-12, 428088-13.
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the d Terminated |
NAY | None listed |
| Sep 10, 2015 | Intuitive Surgical, Inc. Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428093-12, 428093-13.
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used wit Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.