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

    BD Surgiphor™ Antimicrobial Irrigation System (910110)

    K Number: K253996 · Decision Feb 25, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    52
    Applicant Total
    5
    Review Days
    75

    Basic Information

    Device Name
    BD Surgiphor™ Antimicrobial Irrigation System (910110)
    K Number
    K253996
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5475
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson and Company (BD)
    Date Received
    December 12, 2025
    Decision Date
    February 25, 2026
    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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