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

    PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR

    K Number: K971334 · Decision Jun 11, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    62

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    Basic Information

    Device Name
    PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR
    K Number
    K971334
    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
    April 10, 1997
    Decision Date
    June 11, 1997
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Pilling Weck Group

    K Number Device Name
    K965176 PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS
    K964450 SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
    K964123 REUSABLE TROCAR WITH SLEEVE (COMMON)
    K963815 REUSABLE TROCAR WITH SLEEVE (COMMON)