510(k) K160513 ยท GEX Powered Laser Surgical Instrument
Quanta System Surgical Laser fibers
| Applicant | Quanta System Spa, Solbiate Olona (Va), IT |
| Decision | Substantially Equivalent, Mar 18, 2016 |
| Received | Feb 24, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160513
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2021 | Quanta System, S.p.A. Quanta System Sterile Optical Laser Fiber, reusable Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.