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FDA 510(k)

ENDOASSIST

K-Number: K973249 · 1997-11-26

ApplicantArmstrong Healthcare , Ltd.
Decision Date1997-11-26
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOASSIST is the device name listed in this FDA 510(k) record. The listed applicant is Armstrong Healthcare , Ltd.. It received FDA 510(k) clearance on 1997-11-26 under 510(k) number K973249. 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 ENDOASSIST?

ENDOASSIST is a medical device that received FDA 510(k) clearance on 1997-11-26. The listed applicant is Armstrong Healthcare , Ltd.. The 510(k) number is K973249.

When did ENDOASSIST receive FDA 510(k) clearance?

ENDOASSIST received FDA 510(k) clearance on 1997-11-26, under 510(k) number K973249.

Who is the listed applicant for ENDOASSIST?

The FDA 510(k) record lists Armstrong Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOASSIST?

The FDA product code for ENDOASSIST is 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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