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FDA 510(k)

NeuroBlate Fusion-S Software V3.17

K-Number: K222983 · 2023-03-15

ApplicantMonteris Medical,
Decision Date2023-03-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NeuroBlate Fusion-S Software V3.17 is the device name listed in this FDA 510(k) record. The listed applicant is Monteris Medical,. It received FDA 510(k) clearance on 2023-03-15 under 510(k) number K222983. 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 Fusion-S Software V3.17?

NeuroBlate Fusion-S Software V3.17 is a medical device that received FDA 510(k) clearance on 2023-03-15. The listed applicant is Monteris Medical,. The 510(k) number is K222983.

When did NeuroBlate Fusion-S Software V3.17 receive FDA 510(k) clearance?

NeuroBlate Fusion-S Software V3.17 received FDA 510(k) clearance on 2023-03-15, under 510(k) number K222983.

Who is the listed applicant for NeuroBlate Fusion-S Software V3.17?

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

What is the FDA product code for NeuroBlate Fusion-S Software V3.17?

The FDA product code for NeuroBlate Fusion-S Software V3.17 is GEX. This falls under the Gastroenterology category.

Other records listing Monteris Medical, as applicant

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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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