NeuroBlate System
K-Number: K260976 · 2026-04-23
ApplicantMonteris Medical
Decision Date2026-04-23
Product CodeONO
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
NeuroBlate System is a medical device manufactured by Monteris Medical. It received FDA 510(k) clearance on 2026-04-23 under approval number K260976. The device is classified under product code ONO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NeuroBlate System?
NeuroBlate System is a medical device that received FDA 510(k) clearance on 2026-04-23. It is manufactured by Monteris Medical. The 510(k) number is K260976.
When was NeuroBlate System approved by the FDA?
NeuroBlate System received FDA 510(k) clearance on 2026-04-23, under approval number K260976.
What company makes NeuroBlate System?
NeuroBlate System is manufactured by Monteris Medical.
What is the FDA product code for NeuroBlate System?
The FDA product code for NeuroBlate System is ONO.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.