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

    SONICISION STERILIZATION TRAY

    K Number: K112536 · Decision Apr 19, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    265
    Registration Numbers
    265
    Same Product Code
    270
    Applicant Total
    80
    Review Days
    231

    Basic Information

    Device Name
    SONICISION STERILIZATION TRAY
    K Number
    K112536
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    COVIDIEN
    Date Received
    September 1, 2011
    Decision Date
    April 19, 2012
    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.

    PAL Sterilization Case

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Aesculap Aicon® Series Container System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ONE TRAY® Sealed Sterilization Container System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Synthes Graphic Case & Tray System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Microdent Sterilization Cassette

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

    Other Clearances by COVIDIEN

    K Number Device Name
    K163055 Reprocessed Kendall SCD Express Foot Cuff
    K163102 ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm
    K160718 Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
    K162941 Ligasure Blunt Tip, Sealer/Divider, Nano-coated
    K162584 VersaOne Bladeless Trocar
    K161804 LigaSure Retractable L-Hook Laparoscopic Sealer/Divider
    K162047 LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated
    K161347 Signia sterilization tray
    K161963 Monoject Enteral Syringe with ENFit Connector
    K161105 Reprocessed Compression Garments
    Search all 80 clearances from COVIDIEN →