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

    KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION

    K Number: K973827 · Decision Feb 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    104
    Review Days
    127

    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
    KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION
    K Number
    K973827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kimberly-Clark Corp.
    Date Received
    October 7, 1997
    Decision Date
    February 11, 1998
    Product Code
    KCT
    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
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

    Similar 510(k) Clearances

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

    SteriBest® Sterilization Tray System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SteriTite Container System with MediTray Products

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Straumann® ProClean™ Cassette (041.800 ; 041.801)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Stainless Steel Surgical Kits

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterilization Trays

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

    Other Clearances by Kimberly-Clark Corp.

    K Number Device Name
    K140963 KIMGUARD SMART-FOLD STERILIZATION WRAP
    K141294 U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS
    K131879 KC 300 SURGICAL MASK
    K131841 KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
    K131254 KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE
    K120985 KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING
    K112805 KIMGUARD ONE-STEP STERILIZATION WRAP
    K113423 KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE
    K112300 KIMGUARD SMART-FOLD* STERILIZATION WRAP
    K112635 U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
    Search all 104 clearances from Kimberly-Clark Corp. →