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

    REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING

    K Number: K930571 · Decision Feb 1, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    5
    Review Days
    362

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    Basic Information

    Device Name
    REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING
    K Number
    K930571
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Numed Technologies, Inc.
    Date Received
    February 4, 1993
    Decision Date
    February 1, 1994
    Product Code
    HFI
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HFI Coagulator, Culdoscopic (And Accessories)

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    Other Clearances by Numed Technologies, Inc.

    K Number Device Name
    K922248 MALLAWANY ATRAUMATIC TISSUE FORCEPS
    K931501 NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST.
    K923126 MALLAWANY TISSUE GRASPING FORCEPS
    K923055 OPERATING SCISSORS FOR LAPAROSCOPIC SURGERIES