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FDA 510(k)

UNI-LASER 470

K-Number: K010885 · 2001-06-07

ApplicantMedart Corp.
Decision Date2001-06-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNI-LASER 470 is the device name listed in this FDA 510(k) record. The listed applicant is Medart Corp.. It received FDA 510(k) clearance on 2001-06-07 under 510(k) number K010885. 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 470?

UNI-LASER 470 is a medical device that received FDA 510(k) clearance on 2001-06-07. The listed applicant is Medart Corp.. The 510(k) number is K010885.

When did UNI-LASER 470 receive FDA 510(k) clearance?

UNI-LASER 470 received FDA 510(k) clearance on 2001-06-07, under 510(k) number K010885.

Who is the listed applicant for UNI-LASER 470?

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 470?

The FDA product code for UNI-LASER 470 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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