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FDA 510(k)

LATERALASE TM

K-Number: K903418 · 1991-06-24

ApplicantTrimedyne, Inc.
Decision Date1991-06-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LATERALASE TM is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1991-06-24 under 510(k) number K903418. 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 LATERALASE TM?

LATERALASE TM is a medical device that received FDA 510(k) clearance on 1991-06-24. The listed applicant is Trimedyne, Inc.. The 510(k) number is K903418.

When did LATERALASE TM receive FDA 510(k) clearance?

LATERALASE TM received FDA 510(k) clearance on 1991-06-24, under 510(k) number K903418.

Who is the listed applicant for LATERALASE TM?

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

What is the FDA product code for LATERALASE TM?

The FDA product code for LATERALASE TM is GEX. This falls under the Gastroenterology category.

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Other records listing Trimedyne, Inc. 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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