510(k) K070157 ยท GEX Powered Laser Surgical Instrument
OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER
| Applicant | Omniguide, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Feb 1, 2007 |
| Received | Jan 17, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070157
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2012 | OmniGuide, Inc. OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use
Cat. # BP-ROBOTIC
The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues includi Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.