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

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

    K Number: K242208 · Decision Oct 7, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    8
    Review Days
    70

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
    K Number
    K242208
    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
    July 29, 2024
    Decision Date
    October 7, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FRG), ordered by most recent decision date.

    Dukal Crepe Paper Sterilization Wrap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterilization Pouch/Roll

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Self-Seal Sterilization Pouch and Roll

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Chex-All Sterilization Pouches and Tubes

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterilization Pouch and Roll

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Primed Medical Products, Inc.

    K Number Device Name
    K252964 PRIMED Surgical and Procedure Masks
    K240286 PRIMED Surgical Masks and PRIMED Procedure Masks
    K233777 PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
    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