510(k) K171255 ยท GEX Powered Laser Surgical Instrument
Monteris Medical NeuroBlate System
| Applicant | Monteris Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Jul 25, 2017 |
| Received | Apr 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171255
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2018 | Monteris Medical Corp MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation. Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.