510(k) K143457 ยท GEX Powered Laser Surgical Instrument
NeuroBlate System
| Applicant | Monteris Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Feb 19, 2015 |
| Received | Dec 3, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K143457
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2016 | Monteris Medical Corp NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01.
NeuroBlate System SideFire Sele Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.