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FDA 510(k)

MONTERIS MEDICAL AUTOLITT LASER PROBE

K-Number: K081509 · 2009-05-01

ApplicantMonteris Medical,
Decision Date2009-05-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONTERIS MEDICAL AUTOLITT LASER PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Monteris Medical,. It received FDA 510(k) clearance on 2009-05-01 under 510(k) number K081509. 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 AUTOLITT LASER PROBE?

MONTERIS MEDICAL AUTOLITT LASER PROBE is a medical device that received FDA 510(k) clearance on 2009-05-01. The listed applicant is Monteris Medical,. The 510(k) number is K081509.

When did MONTERIS MEDICAL AUTOLITT LASER PROBE receive FDA 510(k) clearance?

MONTERIS MEDICAL AUTOLITT LASER PROBE received FDA 510(k) clearance on 2009-05-01, under 510(k) number K081509.

Who is the listed applicant for MONTERIS MEDICAL AUTOLITT LASER PROBE?

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 MONTERIS MEDICAL AUTOLITT LASER PROBE?

The FDA product code for MONTERIS MEDICAL AUTOLITT LASER PROBE 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.

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