BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    HC-1 AND HC-1 CLASSIC

    K Number: K131852 · Decision Apr 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    300

    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
    HC-1 AND HC-1 CLASSIC
    K Number
    K131852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5220
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Transcendencias Comerciales SL Transcom
    Date Received
    June 21, 2013
    Decision Date
    April 17, 2014
    Product Code
    KPL
    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
    KPL Colonic Irrigation System

    Similar 510(k) Clearances

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

    Bio Fluff System

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

    Colonic Plus Regular, Small, and Straight Shape Hydrokit

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

    Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10

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

    AQUA CLEANSE

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

    THE WATER LILY

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

    COLONIC & ENEMA NOZZLE

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