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

    HEMORRHOIDAL LIGATOR WITH SUCTION

    K Number: K900086 · Decision Mar 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    22
    Applicant Total
    505
    Review Days
    74

    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
    HEMORRHOIDAL LIGATOR WITH SUCTION
    K Number
    K900086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    January 4, 1990
    Decision Date
    March 19, 1990
    Product Code
    KDH
    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
    KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

    Similar 510(k) Clearances

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

    GILTECH PLUS CONNECTING TUBE SET

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

    SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS

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

    COMBIPORT FLUID LAVAGE DEVICE

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

    TUM-E-VAC

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

    EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT

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

    FLUSHING IRRIGATION SET

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

    Other Clearances by Baxter Healthcare Corp

    K Number Device Name
    K190910 PrisMax System Version 2
    K163530 PrisMax Control Unit
    K130531 ULTRAFUSE
    K132734 NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
    K130245 LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
    K123874 INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
    K123868 INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET
    K121092 FLOWEASE [SUBCUTANEOUS] INFUSION SET
    K113227 NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
    K111217 ADDITIVE CAP
    Search all 505 clearances from Baxter Healthcare Corp →