NeuroBlate System
FDA 510(k) clearance K143457 · decided 2015-02-19
Clearance details
- K-number
- K143457
- Device name
- NeuroBlate System
- Applicant
- Monteris Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-12-03
- Decision date
- 2015-02-19
- Days to decision
- 78 days
- Clearance type
- Special
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS recall (Z-1614-2016) | Monteris Medical Corp | 2016-05-16 |