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

    STOMACH, GASTRO-ENTEROSTOMY

    K Number: K902421 · Decision Nov 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    22
    Applicant Total
    13
    Review Days
    173

    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
    STOMACH, GASTRO-ENTEROSTOMY
    K Number
    K902421
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Gainor Medical Europe, Ltd.
    Date Received
    May 31, 1990
    Decision Date
    November 20, 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 Gainor Medical Europe, Ltd.

    K Number Device Name
    K926448 I.V. ADMINISTRATION SET
    K931828 CARELET SAFETY LANCET
    K931827 CLEANLET, CLEANLET XL & KIDS
    K922441 SURESEAL BANDAGE
    K913333 I.V. PRIMING SET
    K902422 NEEDLE, ASPIRATION & INJECTION, DISPOSABLE
    K902420 CATHETER, NASAL, OXYGEN
    K902564 NEEDLE, DIALYSIS
    K902426 HEMODIALYSIS SYSTEM AND ACCESSORY
    K902416 SURELITE AND SURELITE XL BLOOD LANCET
    Search all 13 clearances from Gainor Medical Europe, Ltd. →