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

    STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS

    K Number: K112904 · Decision Jan 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    15
    Review Days
    112

    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
    STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS
    K Number
    K112904
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Case Medical, Inc.
    Date Received
    October 4, 2011
    Decision Date
    January 24, 2012
    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 Case Medical, Inc.

    K Number Device Name
    K252854 SteriTite Container System with MediTray Products
    K221492 SteriTite Container System with MediTray Parts
    K212711 SteriTite Container System with MediTray Products
    K173259 Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories
    K161415 SteriTite Containers System & MediTray Products
    K110682 STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
    K090068 STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS
    K080558 STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
    K022978 STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS
    K023614 STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM
    Search all 15 clearances from Case Medical, Inc. →