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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Monteris Medical, Inc.. It received FDA 510(k) clearance on 2020-08-21 under 510(k) 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. The listed applicant is Monteris Medical, Inc.. The 510(k) number is K201056.

When did NeuroBlate System receive FDA 510(k) clearance?

NeuroBlate System received FDA 510(k) clearance on 2020-08-21, under 510(k) number K201056.

Who is the listed applicant for NeuroBlate System?

The FDA 510(k) record lists Monteris Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuroBlate System?

The FDA product code for NeuroBlate System is GEX. This falls under the Gastroenterology category.

Other records listing Monteris Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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