510(k) K191043 ยท GCJ Laparoscope, General & Plastic Surgery
da Vinci Handheld Camera
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 6, 2019 |
| Received | Apr 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191043
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2019 | Intuitive Surgical, Inc. STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach. Terminated |
KCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.