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

    REUSABLE TROCAR WITH SLEEVE (COMMON)

    K Number: K964123 · Decision Dec 12, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    58

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    Basic Information

    Device Name
    REUSABLE TROCAR WITH SLEEVE (COMMON)
    K Number
    K964123
    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
    October 15, 1996
    Decision Date
    December 12, 1996
    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
    K971334 PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR
    K965176 PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS
    K964450 SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
    K963815 REUSABLE TROCAR WITH SLEEVE (COMMON)