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

    FINESS ENDOSCOPE STERILIZATION TRAY

    K Number: K103213 · Decision Feb 2, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    27
    Review Days
    93

    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
    FINESS ENDOSCOPE STERILIZATION TRAY
    K Number
    K103213
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Entellus Medical, Inc.
    Date Received
    November 1, 2010
    Decision Date
    February 2, 2011
    Product Code
    KCT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    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 Entellus Medical, Inc.

    K Number Device Name
    K220027 Audion ET dilation system
    K163509 XprESS ENT Dilation System
    K163435 Entellus Medical Reinforced Anesthesia Needle
    K152435 PassAssist LED Light Fiber
    K152434 XprESS Multi-Sinus Dilation System
    K142252 XprESS Multi-Sinus Dilation Tool
    K141916 PATHASSIST LED LIGHT FIBER
    K133563 PATHASSIST LIGHT SEEKER
    K132440 XPRESS MULTI-SINUS DILATION TOOL
    K130503 PATHASSIST LED LIGHT FIBER
    Search all 27 clearances from Entellus Medical, Inc. →