BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    REPROCESSED DISPOSABLE TROCARS

    K Number: K013987 · Decision Mar 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    87

    Basic Information

    Device Name
    REPROCESSED DISPOSABLE TROCARS
    K Number
    K013987
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Adven Medical
    Date Received
    December 4, 2001
    Decision Date
    March 1, 2002
    Product Code
    KBG
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KBG Trocar, Sinus

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KBG), ordered by most recent decision date.

    REPROCESSED TROCARS

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    CONTINENT STOMA SYSTEM & ACCESSORIES

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat
    View all

    Other Clearances by Adven Medical

    K Number Device Name
    K021528 REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP
    K012675 REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
    K012676 REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS
    K012694 REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
    K940501 RE-SHARPENABLE SAW BLADES