510(k) K230819 ยท GEX Powered Laser Surgical Instrument
OmniGuide RFID Surgical Laser Fibers
| Applicant | Omni-Guide Holdings, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, Apr 21, 2023 |
| Received | Mar 24, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230819
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.