510(k) K183139 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Endoscope Sterilization Tray
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 1, 2019 |
| Received | Nov 13, 2018 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K183139
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2019 | Intuitive Surgical, Inc. STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - 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.