NEUROBLATE SYSTEM
FDA 510(k) clearance K141983 · decided 2014-08-11
Clearance details
- K-number
- K141983
- Device name
- NEUROBLATE SYSTEM
- Applicant
- Monteris Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-21
- Decision date
- 2014-08-11
- Days to decision
- 21 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
- Alameda, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501- recall (Z-0227-2015) | Monteris Medical Corp | 2014-11-19 |
| FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP50 recall (Z-0228-2015) | Monteris Medical Corp | 2014-11-19 |