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FDA 510(k)

UNI-LASER 430

K-Number: K993815 · 2000-05-11

ApplicantMedart Corp.
Decision Date2000-05-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNI-LASER 430 is the device name listed in this FDA 510(k) record. The listed applicant is Medart Corp.. It received FDA 510(k) clearance on 2000-05-11 under 510(k) number K993815. 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 UNI-LASER 430?

UNI-LASER 430 is a medical device that received FDA 510(k) clearance on 2000-05-11. The listed applicant is Medart Corp.. The 510(k) number is K993815.

When did UNI-LASER 430 receive FDA 510(k) clearance?

UNI-LASER 430 received FDA 510(k) clearance on 2000-05-11, under 510(k) number K993815.

Who is the listed applicant for UNI-LASER 430?

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

What is the FDA product code for UNI-LASER 430?

The FDA product code for UNI-LASER 430 is GEX. This falls under the Gastroenterology category.

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Other records listing Medart Corp. as applicant

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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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