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510(k) Data Aggregation

    K Number
    K253996

    Validate with FDA (Live)

    Date Cleared
    2026-02-25

    (75 days)

    Product Code
    Regulation Number
    880.5475
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds.

    Device Description

    The subject BD Surgiphor™ Antimicrobial Irrigation System is a terminally sterilized 450 mL aqueous solution for irrigation and debridement of wounds. The device includes one screw cap and one bottle of Surgiphor solution (0.5% povidone-iodine (PVP-I)), which is used to loosen and remove wound debris via manual lavage. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the loosening and removal of debris, and foreign materials, including microorganisms, from wounds. The PVP-I in the Surgiphor solution serves as a preservative to ensure that no microbial growth occurs in the solution after the bottle is open.

    AI/ML Overview

    N/A

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