510(k) K124030 ยท GEX Powered Laser Surgical Instrument
COOK HOLMIUM LASER FIBER
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Jul 1, 2013 |
| Received | Dec 28, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K124030
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2017 | Cook Inc. Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.