NeuroBlate System
K-Number: K201056 · 2020-08-21
ApplicantMonteris Medical, Inc.
Decision Date2020-08-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
NeuroBlate System is a medical device manufactured by Monteris Medical, Inc.. It received FDA 510(k) clearance on 2020-08-21 under approval number K201056. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. 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 2020-08-21. It is manufactured by Monteris Medical, Inc.. The 510(k) number is K201056.
When was NeuroBlate System approved by the FDA?
NeuroBlate System received FDA 510(k) clearance on 2020-08-21, under approval number K201056.
What company makes NeuroBlate System?
NeuroBlate System is manufactured by Monteris Medical, Inc..
What is the FDA product code for NeuroBlate System?
The FDA product code for NeuroBlate System is GEX. This falls under the Gastroenterology category.
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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.