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

    MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)

    K Number: K061033 · Decision Dec 12, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    23
    Review Days
    242

    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
    MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)
    K Number
    K061033
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Miltex, Inc.
    Date Received
    April 14, 2006
    Decision Date
    December 12, 2006
    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 Miltex, Inc.

    K Number Device Name
    K101653 MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES
    K092855 MILTEX MEMBRANE TACK KIT
    K083796 MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT
    K072563 MILTEX RIGID CONTAINER SYSTEMS
    K052018 MILTEX LIGATING CLIP
    K050570 MILTEX RIGID STERILIZATION CONTAINER SYSTEM
    K043013 MILTEX LAPAROSCOPIC INSTRUMENTS
    K013888 FIXATION (STEINMANN) PINS
    K954185 RE-BAG MULTI-USE POUCH, LARGE & SMALL
    K823324 DENTAL INSTRUMENTS - PROBES
    Search all 23 clearances from Miltex, Inc. →