510(k) K120561 ยท GEX Powered Laser Surgical Instrument
NEUROBLATE SYSTEM
| Applicant | Monteris Medical, Inc., Winnipeg, Mb, CA |
| Decision | Substantially Equivalent, Apr 1, 2013 |
| Received | Feb 24, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120561
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.