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FDA 510(k)

UNIMEDIX HOLMIUM FIBER

K-Number: K924424 · 1993-04-23

ApplicantUnimedix, Inc.
Decision Date1993-04-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNIMEDIX HOLMIUM FIBER is the device name listed in this FDA 510(k) record. The listed applicant is Unimedix, Inc.. It received FDA 510(k) clearance on 1993-04-23 under 510(k) number K924424. 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 UNIMEDIX HOLMIUM FIBER?

UNIMEDIX HOLMIUM FIBER is a medical device that received FDA 510(k) clearance on 1993-04-23. The listed applicant is Unimedix, Inc.. The 510(k) number is K924424.

When did UNIMEDIX HOLMIUM FIBER receive FDA 510(k) clearance?

UNIMEDIX HOLMIUM FIBER received FDA 510(k) clearance on 1993-04-23, under 510(k) number K924424.

Who is the listed applicant for UNIMEDIX HOLMIUM FIBER?

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

What is the FDA product code for UNIMEDIX HOLMIUM FIBER?

The FDA product code for UNIMEDIX HOLMIUM FIBER is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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