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

    PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS

    K Number: K965176 · Decision Mar 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    73
    Applicant Total
    5
    Review Days
    70

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    Basic Information

    Device Name
    PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS
    K Number
    K965176
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pilling Weck Group
    Date Received
    December 24, 1996
    Decision Date
    March 4, 1997
    Product Code
    OCZ
    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
    OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered

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    Other Clearances by Pilling Weck Group

    K Number Device Name
    K971334 PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR
    K964450 SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
    K964123 REUSABLE TROCAR WITH SLEEVE (COMMON)
    K963815 REUSABLE TROCAR WITH SLEEVE (COMMON)