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

    Ellipse Supplemental Instrument Trays

    K Number: K151594 · Decision Jan 25, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    7
    Review Days
    227

    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
    Ellipse Supplemental Instrument Trays
    K Number
    K151594
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ellipse Technologies, Incorporated
    Date Received
    June 12, 2015
    Decision Date
    January 25, 2016
    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 Ellipse Technologies, Incorporated

    K Number Device Name
    K160267 PRECICE Trauma Nail System
    K152370 PRECICE Trauma Nail System
    K151131 PRECICE Intramedullary Limb Lengthening System
    K150885 MAGEC 2 Spinal Bracing and Distraction System
    K150656 PRECICE Intramedullary Limb Lengthening System
    K142599 PRECISE Trauma Nail System