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

    HAEMOBAND MULTI-LIGATOR

    K Number: K091519 · Decision Jul 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    21
    Applicant Total
    2
    Review Days
    67

    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
    HAEMOBAND MULTI-LIGATOR
    K Number
    K091519
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Haemoband Surgical, Ltd.
    Date Received
    May 22, 2009
    Decision Date
    July 28, 2009
    Product Code
    FHN
    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
    FHN Ligator, Hemorrhoidal

    Similar 510(k) Clearances

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

    Multi-Band Ligator

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

    Ligation Device

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

    Wi-3 HAL-RAR System

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

    NEXUS HEMORRHOID LIGATOR

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

    THD BANDY

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

    LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660

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

    Other Clearances by Haemoband Surgical, Ltd.

    K Number Device Name
    K250645 SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)