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FDA 510(k)

RIGHT ANGLE LASER FIBERS

K-Number: K954597 · 1996-03-11

ApplicantTrimedyne, Inc.
Decision Date1996-03-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RIGHT ANGLE LASER FIBERS is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1996-03-11 under 510(k) number K954597. 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 RIGHT ANGLE LASER FIBERS?

RIGHT ANGLE LASER FIBERS is a medical device that received FDA 510(k) clearance on 1996-03-11. The listed applicant is Trimedyne, Inc.. The 510(k) number is K954597.

When did RIGHT ANGLE LASER FIBERS receive FDA 510(k) clearance?

RIGHT ANGLE LASER FIBERS received FDA 510(k) clearance on 1996-03-11, under 510(k) number K954597.

Who is the listed applicant for RIGHT ANGLE LASER FIBERS?

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 RIGHT ANGLE LASER FIBERS?

The FDA product code for RIGHT ANGLE LASER FIBERS 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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