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

    EPICOR MEDICAL ABLATION SYSTEM

    K Number: K022894 · Decision Feb 26, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    541

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    Basic Information

    Device Name
    EPICOR MEDICAL ABLATION SYSTEM
    K Number
    K022894
    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
    Epicor Medical, Inc.
    Date Received
    September 3, 2002
    Decision Date
    February 26, 2004
    Product Code
    NTB
    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
    NTB System, Ablation, Ultrasound And Accessories

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    Other Clearances by Epicor Medical, Inc.

    K Number Device Name
    K040641 ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1