510(k) K131278 ยท GEX Powered Laser Surgical Instrument
MONTERIS MEDICAL NEUROBLATE SYSTEM
| Applicant | Monteris Medical, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Jul 11, 2013 |
| Received | May 6, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131278
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2014 | Monteris Medical Corp FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devi Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.