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FDA 510(k)

DURALITE-GL

K-Number: K041262 · 2004-08-13

ApplicantLaser Scientific
Decision Date2004-08-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DURALITE-GL is the device name listed in this FDA 510(k) record. The listed applicant is Laser Scientific. It received FDA 510(k) clearance on 2004-08-13 under 510(k) number K041262. 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 DURALITE-GL?

DURALITE-GL is a medical device that received FDA 510(k) clearance on 2004-08-13. The listed applicant is Laser Scientific. The 510(k) number is K041262.

When did DURALITE-GL receive FDA 510(k) clearance?

DURALITE-GL received FDA 510(k) clearance on 2004-08-13, under 510(k) number K041262.

Who is the listed applicant for DURALITE-GL?

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

What is the FDA product code for DURALITE-GL?

The FDA product code for DURALITE-GL 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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