NeuroBlate System— 510(k) K262315
Substantially EquivalentMonteris Medical
FDA 510(k) clearance K262315 for NeuroBlate System, Substantially Equivalent on 2026-09-03. Applicant: Monteris Medical. Device class: 2.
Summary
Monteris Medical's NeuroBlate System is filed under ONO, neurosurgical lasers with MR thermography. The record doesn't describe the system's components.
Class II, 21 CFR 878.4810. The Neurology review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Monteris filed from Minnetonka, Minnesota. The decision came 57 calendar days after FDA received it (July 8 to September 3, 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
- Traditional
- Location
- Minnetonka, MN, US
Recent devices under product code ONO
view allMore clearances from Monteris Medical
view allData sourced from openFDA. This site is unofficial and independent of the FDA.