BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR)

    K Number: K062008 · Decision Aug 9, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    112
    Registration Numbers
    112
    Same Product Code
    175
    Applicant Total
    6
    Review Days
    23

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    Basic Information

    Device Name
    ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR)
    K Number
    K062008
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Niti Medical Technologies , Ltd.
    Date Received
    July 17, 2006
    Decision Date
    August 9, 2006
    Product Code
    FZP
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FZP Clip, Implantable

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    Other Clearances by Niti Medical Technologies , Ltd.

    K Number Device Name
    K050356 COMPRESSION ANASTOMOSIS RING (CAR)
    K043115 LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC)
    K042492 HAND STC, MODEL 60MM
    K041751 COMPRESSION ANASTOMOSIS CLIP (CAC)
    K033324 COMPRESSION ANASTOMOSIS CLIP (CAC)