510(k) K112263 ยท NAY System, Surgical, Computer Controlled Instrument
MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 7, 2011 |
| Received | Aug 8, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112263
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2012 | Intuitive Surgical, Inc. Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10.
The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of th Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.