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

    ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO

    K Number: K003405 · Decision May 7, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    43
    Applicant Total
    2
    Review Days
    187

    Basic Information

    Device Name
    ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO
    K Number
    K003405
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HIGHLAND / MARIETTA, INC.
    Date Received
    November 1, 2000
    Decision Date
    May 7, 2001
    Product Code
    KNF
    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
    KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

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    Other Clearances by HIGHLAND / MARIETTA, INC.

    K Number Device Name
    K003403 ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999