510(k) K141077 ยท NAY System, Surgical, Computer Controlled Instrument
DA VINCI FIREFLY IMAGING SYSTEM
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 12, 2014 |
| Received | Apr 25, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141077
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2015 | Intuitive Surgical, Inc. Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems;
Model numbers: 950156-01, 950156-02, 950156-03.
Product Usage: General and plastic surgery: The da Vinci Firefl Terminated |
NAY | None listed |
| Dec 19, 2014 | Intuitive Surgical, Inc. Fluorescence Imaging Procedure Kit, designed
for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.