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FDA 510(k)

Monteris Medical NeuroBlate System

K-Number: K171255 · 2017-07-25

ApplicantMonteris Medical, Inc.
Decision Date2017-07-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Monteris Medical NeuroBlate System is a medical device manufactured by Monteris Medical, Inc.. It received FDA 510(k) clearance on 2017-07-25 under approval number K171255. 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 Monteris Medical NeuroBlate System?

Monteris Medical NeuroBlate System is a medical device that received FDA 510(k) clearance on 2017-07-25. It is manufactured by Monteris Medical, Inc.. The 510(k) number is K171255.

When was Monteris Medical NeuroBlate System approved by the FDA?

Monteris Medical NeuroBlate System received FDA 510(k) clearance on 2017-07-25, under approval number K171255.

What company makes Monteris Medical NeuroBlate System?

Monteris Medical NeuroBlate System is manufactured by Monteris Medical, Inc..

What is the FDA product code for Monteris Medical NeuroBlate System?

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

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Monteris Medical, Inc.

K162762NeuroBlate System K201056NeuroBlate System

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Official Source

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