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FDA 510(k)

METAL ENCLOSED SIDE FIRING FIBERS

K-Number: K915223 · 1992-01-23

ApplicantTrimedyne, Inc.
Decision Date1992-01-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

METAL ENCLOSED SIDE FIRING 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 1992-01-23 under 510(k) number K915223. 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 METAL ENCLOSED SIDE FIRING FIBERS?

METAL ENCLOSED SIDE FIRING FIBERS is a medical device that received FDA 510(k) clearance on 1992-01-23. The listed applicant is Trimedyne, Inc.. The 510(k) number is K915223.

When did METAL ENCLOSED SIDE FIRING FIBERS receive FDA 510(k) clearance?

METAL ENCLOSED SIDE FIRING FIBERS received FDA 510(k) clearance on 1992-01-23, under 510(k) number K915223.

Who is the listed applicant for METAL ENCLOSED SIDE FIRING 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 METAL ENCLOSED SIDE FIRING FIBERS?

The FDA product code for METAL ENCLOSED SIDE FIRING FIBERS is GEX. This falls under the Gastroenterology category.

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Other records listing Trimedyne, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K053457VAPORMAX IIK050412VAPORMAXK043012OMNIPULSE MINI, MODEL 2120K041660TRIMEDYNE HOLMIUM LASER SYSTEMSK022655TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATHK013974RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A

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Related Devices (Code: GEX)

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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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