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FDA 510(k)

HALOCATH LASER CATHETERS

K-Number: K920934 · 1992-04-29

ApplicantTrimedyne, Inc.
Decision Date1992-04-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HALOCATH LASER CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1992-04-29 under 510(k) number K920934. 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 HALOCATH LASER CATHETERS?

HALOCATH LASER CATHETERS is a medical device that received FDA 510(k) clearance on 1992-04-29. The listed applicant is Trimedyne, Inc.. The 510(k) number is K920934.

When did HALOCATH LASER CATHETERS receive FDA 510(k) clearance?

HALOCATH LASER CATHETERS received FDA 510(k) clearance on 1992-04-29, under 510(k) number K920934.

Who is the listed applicant for HALOCATH LASER CATHETERS?

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 HALOCATH LASER CATHETERS?

The FDA product code for HALOCATH LASER CATHETERS 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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