BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    MODIFICATION TO WARTNER WART REMOVAL SYSTEM

    K Number: K011708 · Decision Feb 20, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    3
    Review Days
    261

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    Basic Information

    Device Name
    MODIFICATION TO WARTNER WART REMOVAL SYSTEM
    K Number
    K011708
    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
    Wartner Medical Products
    Date Received
    June 4, 2001
    Decision Date
    February 20, 2002
    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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    Other Clearances by Wartner Medical Products

    K Number Device Name
    K030838 WARTNER PRO
    K002714 WARTNER WART REMOVAL SYSTEM