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FDA 510(k)

ENDOXFLEX 5000

K-Number: K946239 · 1995-01-30

ApplicantMichael A Clark
Decision Date1995-01-30
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOXFLEX 5000 is the device name listed in this FDA 510(k) record. The listed applicant is Michael A Clark. It received FDA 510(k) clearance on 1995-01-30 under 510(k) number K946239. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOXFLEX 5000?

ENDOXFLEX 5000 is a medical device that received FDA 510(k) clearance on 1995-01-30. The listed applicant is Michael A Clark. The 510(k) number is K946239.

When did ENDOXFLEX 5000 receive FDA 510(k) clearance?

ENDOXFLEX 5000 received FDA 510(k) clearance on 1995-01-30, under 510(k) number K946239.

Who is the listed applicant for ENDOXFLEX 5000?

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

What is the FDA product code for ENDOXFLEX 5000?

The FDA product code for ENDOXFLEX 5000 is GCJ.

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Related Devices (Code: GCJ)

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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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