BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES

    K Number: K012660 · Decision Dec 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    97
    Applicant Total
    6
    Review Days
    129

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    Basic Information

    Device Name
    GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
    K Number
    K012660
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gimmi GmbH
    Date Received
    August 13, 2001
    Decision Date
    December 20, 2001
    Product Code
    FET
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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    Other Clearances by Gimmi GmbH

    K Number Device Name
    K092421 ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC
    K093125 ALPHAXENON LIGHT 180 W AND 300 W
    K081640 GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
    K012869 GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25
    K013731 GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03