NeuroBlate System— 510(k) K260976
Substantially EquivalentMonteris Medical
FDA 510(k) clearance K260976 for NeuroBlate System, Substantially Equivalent on 2026-04-23. Applicant: Monteris Medical. Device class: 2.
Summary
Monteris Medical's NeuroBlate System is filed under product code ONO (Neurosurgical Laser With Mr Thermography). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 878.4810. The Neurology review panel handled it as a Special 510(k), though the record lists General and Plastic Surgery as the classification panel.
Monteris Medical filed from Minnetonka, Minnesota. The record shows 30 calendar days from receipt to decision (March 24 to April 23, 2026).
Clearance details
- Applicant
- Monteris Medical
- Product code
- Product code ONO
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minnetonka, MN, US
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