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

    MILL-ROSE ROTATABLE POLYPECTOMY SNARE

    K Number: K951600 · Decision Dec 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    62
    Applicant Total
    46
    Review Days
    255

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    Basic Information

    Device Name
    MILL-ROSE ROTATABLE POLYPECTOMY SNARE
    K Number
    K951600
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mill-Rose Laboratory
    Date Received
    April 7, 1995
    Decision Date
    December 18, 1995
    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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