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

    ENDOCERVICAL ELECTRODE # 2

    K Number: K070877 · Decision Jul 27, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    52
    Applicant Total
    14
    Review Days
    120

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    Basic Information

    Device Name
    ENDOCERVICAL ELECTRODE # 2
    K Number
    K070877
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4120
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Modern Medical Equipment Mfg., Ltd.
    Date Received
    March 29, 2007
    Decision Date
    July 27, 2007
    Product Code
    HGI
    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
    HGI Electrocautery, Gynecologic (And Accessories)

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    Other Clearances by Modern Medical Equipment Mfg., Ltd.

    K Number Device Name
    K093479 DISPOSABLE SUCTION AND IRRIGATION SYSTEM
    K091511 MODERN MEDICAL RESECTOSCOPE ELECTRODES
    K070812 DISPOSABLE LAPAROSCOPIC INSTRUMENT
    K050842 AGCEL WOUND DRESSING,AGCEL BURN DRESSING
    K043036 NON-STICK ELECTRODE
    K033095 SMOKE EVACUATION ATTACHEMENT
    K040238 SOFTSEAL HSG CATHETER
    K032327 MODERN MEDICAL BIPOLAR FORCEPS
    K030831 LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS
    K033003 SUCTION COAGULATOR
    Search all 14 clearances from Modern Medical Equipment Mfg., Ltd. →