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

    DISPOSABLE HEMOSTASIS CHIP

    K Number: K121505 · Decision Aug 31, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    62
    Applicant Total
    7
    Review Days
    102

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    Basic Information

    Device Name
    DISPOSABLE HEMOSTASIS CHIP
    K Number
    K121505
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wilson-Cook Medical Inc./Cook Endoscopy
    Date Received
    May 21, 2012
    Decision Date
    August 31, 2012
    Product Code
    PKL
    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
    PKL Hemostatic Metal Clip For The Gi Tract

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    Other Clearances by Wilson-Cook Medical Inc./Cook Endoscopy

    K Number Device Name
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    K172288 Fusion OMNI Sphincterotome
    K171993 Zimmon Needle Knife Papillotome
    K171607 Bronchi and Gastrointestinal Cytology Brush
    K111895 ECHOTIP(R) ULTRA FIDUCIAL NEEDLE