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

    CAM-WRAP(TM) NEW STERILIZATION PROCEDURE

    K Number: K891983 · Decision Apr 19, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    18
    Review Days
    22

    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
    CAM-WRAP(TM) NEW STERILIZATION PROCEDURE
    K Number
    K891983
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Medical Dynamics, Inc.
    Date Received
    March 28, 1989
    Decision Date
    April 19, 1989
    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 Medical Dynamics, Inc.

    K Number Device Name
    K974542 TRUE VISION, TRUE VISION II
    K921294 VIDEO ENDOSCOPE-RIGID MODIFICATION
    K934682 SURGICAL VIDEO CAMERA AND ACCESSORIES
    K930568 ADAIR/VERESS NEEDLE INTRODUCER SET
    K915538 OVER THE WIRE STONE BASKET
    K914315 OPTICAL CATHETER INTRODUCER SETS, MODIFICATION
    K913986 CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM
    K911296 OPTICAL CATHETER ARTHROSCOPE
    K903339 VIDEO ENDOSCOPE, RIGID
    K904609 XENON LIGHT SOURCE
    Search all 18 clearances from Medical Dynamics, Inc. →