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

    C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)

    K Number: K240457 · Decision Jul 24, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    44
    Review Days
    159

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    Basic Information

    Device Name
    C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
    K Number
    K240457
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentax of America, Inc.
    Date Received
    February 16, 2024
    Decision Date
    July 24, 2024
    Product Code
    GEH
    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
    GEH Unit, Cryosurgical, Accessories

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