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

    OPERATING SCISSORS FOR LAPAROSCOPIC SURGERIES

    K Number: K923055 · Decision Nov 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    152

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    Basic Information

    Device Name
    OPERATING SCISSORS FOR LAPAROSCOPIC SURGERIES
    K Number
    K923055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Numed Technologies, Inc.
    Date Received
    June 24, 1992
    Decision Date
    November 23, 1992
    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 Numed Technologies, Inc.

    K Number Device Name
    K922248 MALLAWANY ATRAUMATIC TISSUE FORCEPS
    K930571 REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING
    K931501 NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST.
    K923126 MALLAWANY TISSUE GRASPING FORCEPS