BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS

    K Number: K081640 · Decision May 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    35
    Applicant Total
    6
    Review Days
    329

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    Basic Information

    Device Name
    GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
    K Number
    K081640
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    882.5200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gimmi GmbH
    Date Received
    June 11, 2008
    Decision Date
    May 6, 2009
    Product Code
    HCH
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HCH Clip, Aneurysm

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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
    K012869 GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25
    K012660 GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
    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