BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

    K Number: K233777 · Decision May 24, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    8
    Review Days
    182

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    Basic Information

    Device Name
    PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
    K Number
    K233777
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Primed Medical Products, Inc.
    Date Received
    November 24, 2023
    Decision Date
    May 24, 2024
    Product Code
    FRG
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FRG Wrap, Sterilization

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    Other Clearances by Primed Medical Products, Inc.

    K Number Device Name
    K252964 PRIMED Surgical and Procedure Masks
    K242208 PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
    K240286 PRIMED Surgical Masks and PRIMED Procedure Masks
    K213427 PRIMED Pediatric Facemask
    K160361 PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
    K092012 PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70
    K081633 PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS