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

    SUCTION WOUND DRAINAGE DEVICE

    K Number: K810739 · Decision Jun 26, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    13
    Applicant Total
    6
    Review Days
    99

    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
    SUCTION WOUND DRAINAGE DEVICE
    K Number
    K810739
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4370
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    The Urology Group
    Date Received
    March 19, 1981
    Decision Date
    June 26, 1981
    Product Code
    KQT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KQT Evacuator, Gastro-Urology

    Similar 510(k) Clearances

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

    LITHOVAC SUCTION/ASPIRATION PROBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EVACUATOR, GASTRO-UROLOGY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EVACUATOR, GASTRO-UROLOGY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CLEANFLOW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VAN-TEC BLADDER EVACUATOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BELLA - VAC IRRIGATOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by The Urology Group

    K Number Device Name
    K831703 COVERUPS
    K831489 SURGICAL TUBE HOLDER
    K810788 SURGICAL TUBE HOLDER
    K810787 UROLOGIC TUBE HOLDER
    K801629 COVER-ALL MALE INCONTINENCE DEVICE