510(k) K131955 ยท GEX Powered Laser Surgical Instrument
NEUROBLATE(TM) SYSTEM
| Applicant | Monteris Medical, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Jul 30, 2013 |
| Received | Jun 27, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131955
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2014 | Monteris Medical Corp SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser device Terminated |
GEX | None listed |
| 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.