BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    MODERN MEDICAL RESECTOSCOPE ELECTRODES

    K Number: K091511 · Decision Jan 15, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    57
    Applicant Total
    14
    Review Days
    238

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    Basic Information

    Device Name
    MODERN MEDICAL RESECTOSCOPE ELECTRODES
    K Number
    K091511
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Modern Medical Equipment Mfg., Ltd.
    Date Received
    May 22, 2009
    Decision Date
    January 15, 2010
    Product Code
    FAS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FAS Electrode, Electrosurgical, Active, Urological

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    Other Clearances by Modern Medical Equipment Mfg., Ltd.

    K Number Device Name
    K093479 DISPOSABLE SUCTION AND IRRIGATION SYSTEM
    K070812 DISPOSABLE LAPAROSCOPIC INSTRUMENT
    K070877 ENDOCERVICAL ELECTRODE # 2
    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. →