510(k) K073496 ยท GEX Powered Laser Surgical Instrument
OPTILITE HOLMIUM LASER FIBERS
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Jan 23, 2008 |
| Received | Dec 12, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073496
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2017 | Cook Inc. OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Product Usage:
Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary c Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.