Company ยท US
Monteris Medical,
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2026. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (2 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 3, 2026 | K262315 | NeuroBlate System Monteris Medical | ONO |
| Apr 23, 2026 | K260976 | NeuroBlate System Monteris Medical | ONO |
| Jun 4, 2024 | K240877 | Monteris Medical NeuroBlate System Monteris Medical, | ONO |
| Dec 8, 2023 | K231061 | NeuroBlate System Monteris Medical, | GEX |
| Mar 15, 2023 | K222983 | NeuroBlate Fusion-S Software V3.17 Monteris Medical, | GEX |
| Aug 21, 2020 | K201056 | NeuroBlate System Monteris Medical, Inc. | GEX |
| Jan 3, 2020 | K193375 | NeuroBlate System Monteris Medical, | GEX |
| Oct 15, 2018 | K182036 | NeuroBlate System Monteris Medical, | GEX |
| Nov 17, 2017 | K173305 | NeuroBlate System Monteris Medical, | GEX |
| Oct 20, 2017 | K172881 | NeuroBlate System Monteris Medical, | GEX |
| Jul 25, 2017 | K171255 | Monteris Medical NeuroBlate System Monteris Medical, Inc. | GEX |
| Apr 7, 2017 | K170724 | NeuroBlate System Monteris Medical, | GEX |
| Oct 26, 2016 | K162762 | NeuroBlate System Monteris Medical, Inc. | GEX |
| Feb 19, 2015 | K143457 | NeuroBlate System Monteris Medical, Inc. | GEX |
| Aug 11, 2014 | K141983 | NEUROBLATE SYSTEM Monteris Medical Corp. | GEX |
| Jan 27, 2014 | K132444 | ATAMA SYSTEM Monteris Medical, | MOS |
| Jul 30, 2013 | K131955 | NEUROBLATE(TM) SYSTEM Monteris Medical, Inc. | GEX |
| Jul 11, 2013 | K131278 | MONTERIS MEDICAL NEUROBLATE SYSTEM Monteris Medical, Inc. | GEX |
| Apr 1, 2013 | K120561 | NEUROBLATE SYSTEM Monteris Medical, Inc., CA | GEX |
| Apr 8, 2011 | K110411 | ATAMA SYSTEM Monteris Medical, Inc., CA | MOS |
| Aug 6, 2009 | K090240 | MONTERIS MEDICAL UFO Monteris Medical, | HAW |
| May 1, 2009 | K081509 | MONTERIS MEDICAL AUTOLITT LASER PROBE Monteris Medical, | GEX |
Latest recalls
| 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 | K171255 |
| 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 | K143457 |
| 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 | K131278 K131955 +1 |
| 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 | K120561 K131955 +1 |