510(k) K140378 ยท GEX Powered Laser Surgical Instrument
FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT
| Applicant | Omniguide, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Sep 25, 2014 |
| Received | Feb 14, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140378
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.