NeuroBlate System— 510(k) K262315

Substantially Equivalent

Monteris Medical

FDA 510(k) clearance K262315 for NeuroBlate System, Substantially Equivalent on 2026-09-03. Applicant: Monteris Medical. Device class: 2.

Clearance details

Applicant: Monteris Medical
Product code: Code ONO
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2026-07-08
Decision date: 2026-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ONO

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K250307 — Visualase V2 MRI-guided Laser Ablation System (9736422)2025-05-29
K240877 — Monteris Medical NeuroBlate System2024-06-04

More clearances from Monteris Medical

K231061 — NeuroBlate System2023-12-08
K222983 — NeuroBlate Fusion-S Software V3.172023-03-15
K193375 — NeuroBlate System2020-01-03
K182036 — NeuroBlate System2018-10-15
K173305 — NeuroBlate System2017-11-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.