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

    IRRIGATION/ASPIRATION POLYPECTOMY

    K Number: K970356 · Decision Mar 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    62
    Applicant Total
    94
    Review Days
    54

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    Basic Information

    Device Name
    IRRIGATION/ASPIRATION POLYPECTOMY
    K Number
    K970356
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    United States Endoscopy Group, Inc.
    Date Received
    January 30, 1997
    Decision Date
    March 25, 1997
    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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