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

    CLEARWATER COLON HYDROTHERAPY MODEL PPC-101

    K Number: K942867 · Decision Jun 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    39
    Applicant Total
    2
    Review Days
    740

    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
    CLEARWATER COLON HYDROTHERAPY MODEL PPC-101
    K Number
    K942867
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5220
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Clearwater Colon Hydrotherapy, Inc.
    Date Received
    June 17, 1994
    Decision Date
    June 26, 1996
    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

    HC-1 AND HC-1 CLASSIC

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

    THE WATER LILY

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

    Other Clearances by Clearwater Colon Hydrotherapy, Inc.

    K Number Device Name
    K000388 CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)