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FDA 510(k)

ENDOASSIST

K-Number: K043284 · 2005-02-25

ApplicantArmstrong Healthcare Limited
Decision Date2005-02-25
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 Limited. It received FDA 510(k) clearance on 2005-02-25 under 510(k) number K043284. 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 2005-02-25. The listed applicant is Armstrong Healthcare Limited. The 510(k) number is K043284.

When did ENDOASSIST receive FDA 510(k) clearance?

ENDOASSIST received FDA 510(k) clearance on 2005-02-25, under 510(k) number K043284.

Who is the listed applicant for ENDOASSIST?

The FDA 510(k) record lists Armstrong Healthcare Limited 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.

Related Clinical Trials

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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Other records listing Armstrong Healthcare Limited 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.

K041477PATHFINDER

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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