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

    ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999

    K Number: K003403 · Decision May 7, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    187

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    Basic Information

    Device Name
    ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999
    K Number
    K003403
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Highland / Marietta, Inc.
    Date Received
    November 1, 2000
    Decision Date
    May 7, 2001
    Product Code
    JOS
    Advisory Committee
    General, Plastic Surgery
    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
    JOS Electrode, Electrosurgical

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    Other Clearances by Highland / Marietta, Inc.

    K Number Device Name
    K003405 ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO