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FDA 510(k)

LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE

K-Number: K896618 · 1990-01-09

ApplicantLuxar Corp.
Decision Date1990-01-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Luxar Corp.. It received FDA 510(k) clearance on 1990-01-09 under 510(k) number K896618. 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 LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE?

LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE is a medical device that received FDA 510(k) clearance on 1990-01-09. The listed applicant is Luxar Corp.. The 510(k) number is K896618.

When did LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE receive FDA 510(k) clearance?

LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE received FDA 510(k) clearance on 1990-01-09, under 510(k) number K896618.

Who is the listed applicant for LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE?

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

What is the FDA product code for LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE?

The FDA product code for LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE is GEX. This falls under the Gastroenterology category.

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Other records listing Luxar Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960475MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEMK953074MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEMK945888MODIFIED LUXAR LX-20 FAMILY C02 LASER SYSTEMK904068LUXAR MODEL LX-20 CO2 LASERK903079ENDOGUIDE (R), MICROGUIDE (TM), FLEXIGUIDE (TM)K900066FLEXIGUIDE(TM) CO2 LASER HOLLOW FLEXIBLE FIBER

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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