510(k) clearance
NeuroBlate System
- 510(k) number
- K262315
- Applicant
- Monteris Medical
- Decision date
- Sep 3, 2026
- Date received
- Jul 8, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- ONO
- Device type
- Neurosurgical Laser With Mr Thermography
- Device class
- Class II
- Regulation
- 21 CFR 878.4810
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Minnetonka, MN, US