510(k) K120215 ยท NAY System, Surgical, Computer Controlled Instrument
SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Unknown, Apr 30, 2012 |
| Received | Jan 24, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120215
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2015 | Intuitive Surgical, Inc. Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428053-12, 428053-15.
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with Terminated |
NAY | None listed |
| Sep 10, 2015 | Intuitive Surgical, Inc. Fundus Grasper; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428058-12, 428058-13.
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinc Terminated |
NAY | None listed |
| Sep 10, 2015 | Intuitive Surgical, Inc. Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428059-12, 428059-13.
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da V Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.