510(k) K180158 ยท GEX Powered Laser Surgical Instrument
Surgical Laser fibers
| Applicant | Quanta System Spa, Samarate, IT |
| Decision | Substantially Equivalent, Feb 14, 2018 |
| Received | Jan 19, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180158
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2021 | Quanta System, S.p.A. Olympus Sterile Optical Laser Fiber, single use and reusable Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.