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

    COX DIAPOSABLE POLYPECTOMY SNARE

    K Number: K912254 · Decision Jul 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    62
    Applicant Total
    15
    Review Days
    66

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    Basic Information

    Device Name
    COX DIAPOSABLE POLYPECTOMY SNARE
    K Number
    K912254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cox Medical Ent., Inc.
    Date Received
    May 21, 1991
    Decision Date
    July 26, 1991
    Product Code
    FDI
    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
    FDI Snare, Flexible

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