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510(k) Data Aggregation

    K Number
    K253445

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-02-20

    (141 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™ 1000 mL Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds.

    Device Description

    The subject BD Surgiphor™ 1000 mL Antimicrobial Irrigation System is a terminally sterilized 1000 mL aqueous solution for irrigation and debridement of wounds. The device includes one bottle of Surgiphor™ solution (0.5% povidone-iodine) which is used to loosen and remove wound debris via manual lavage or a powered lavage device. Components are included with the bottle in the system tray to support each lavage type; one screw cap for manual irrigation and one adaptor and one Y-connector for powered irrigation. 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 povidone-iodine 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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