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

    IRRISEPT WOUND CLEANSING SYSTEM

    K Number: K080779 · Decision Feb 4, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    52
    Applicant Total
    5
    Review Days
    322

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    Basic Information

    Device Name
    IRRISEPT WOUND CLEANSING SYSTEM
    K Number
    K080779
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5475
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Irrimax Corporation
    Date Received
    March 19, 2008
    Decision Date
    February 4, 2009
    Product Code
    FQH
    Advisory Committee
    General Hospital
    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
    FQH Lavage, Jet

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    Other Clearances by Irrimax Corporation

    K Number Device Name
    K240552 Irrisept Antimicrobial Wound Lavage
    K222804 Irrisept Antimicrobial Wound Lavage
    K210536 Irrisept Antimicrobial Wound Lavage
    K202222 Irrisept Wound Debridement and Cleansing System