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FDA 510(k)

CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER

K-Number: K903154 · 1990-11-23

ApplicantTrimedyne, Inc.
Decision Date1990-11-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1990-11-23 under 510(k) number K903154. 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 CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER?

CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER is a medical device that received FDA 510(k) clearance on 1990-11-23. The listed applicant is Trimedyne, Inc.. The 510(k) number is K903154.

When did CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER receive FDA 510(k) clearance?

CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER received FDA 510(k) clearance on 1990-11-23, under 510(k) number K903154.

Who is the listed applicant for CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER?

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 CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER?

The FDA product code for CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER 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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