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

    HEM-AVERT PERIANAL STABILIZER

    K Number: DEN090011 · Decision Jan 13, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    513

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    Basic Information

    Device Name
    HEM-AVERT PERIANAL STABILIZER
    K Number
    DEN090011
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    884.5200
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Unknown
    Applicant
    Plexus Biomedical, Inc.
    Date Received
    August 18, 2009
    Decision Date
    January 13, 2011
    Product Code
    OOA
    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
    OOA Hemorrhoid Prevention Pressure Wedge