BEUDAMED
    Product Code: KPL FDA class 2 21 CFR 876.5220

    Colonic Irrigation System

    Gastroenterology, Urology

    This device is a colonic irrigation system used to flush the large intestine with water or other solutions, employed therapeutically to cleanse the colon prior to procedures or in the management of certain bowel conditions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPL, regulated under 21 CFR 876.5220 within the Gastroenterology and Urology specialty. No special flags apply.

    View on FDA
    510(k)s
    40
    FEI Numbers
    14
    Registration Numbers
    14
    Unique Applicants
    27
    Years Active
    45

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    Basic Information

    Product Code
    KPL
    Device Class
    FDA class 2
    Regulation Number
    876.5220
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 40 510(k) clearances via K numbers.

    K Number Device Name
    K201861 Bio Fluff System
    K180800 Colonic Plus Regular, Small, and Straight Shape Hydrokit
    K152834 Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
    K150381 AQUA CLEANSE
    K131852 HC-1 AND HC-1 CLASSIC
    K094022 THE WATER LILY
    K071057 COLONIC & ENEMA NOZZLE
    K051344 COLONIC AND ENEMA NOZZLE
    K050992 CONMED IRRIGATION NOZZLE
    K050112 PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
    K033149 ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM
    K003720 ANGEL OF WATER COLON HYDROTHERAPY SYSTEM
    K002102 GENTLE COLONICS IRRIGATION SYSTEM
    K000031 AQUANET, MODEL EC 2000
    K000388 CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
    K980868 GC IRRIGATOR
    K970482 TRANSCOM COLON HYDROTHERAPY MODEL HC-2000
    K973256 JIMMY JOHN III RECTAL NOZZLE
    K972455 JIMMY JOHN III RECTAL NOZZEL, MODEL CIT
    K962259 LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)
    K942867 CLEARWATER COLON HYDROTHERAPY MODEL PPC-101
    K941279 LOWER BOWEL EVACUATION SYSTEM
    K902993 SYSTEMS FLOW 2000
    K894209 ENEMA KIT
    K891585 HYDRO-SAN COLONIC IRRIGATION SYSTEM
    K893531 CUFF SPECULUM
    K885092 BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002
    K881720 JIMMY JOHN III
    K873948 MODIFIED RECTAL NOZZLE
    K870534 DOTOLO COLON HYDROTHERAPY INSTRUMENT
    K870376 JIMMY JOHN III, COLONIC IRRIGATION SYSTEM
    K870127 MODIFIED JIMMY JOHN III
    K863539 HYDRO-CLENZ UNIT
    K860943 JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION)
    K842083 JIMMY JOHN III
    K840613 COLON IRRIGATION UNIT
    K803105 SARNS INFANT ARTERIAL BUBBLE SENSOR
    K800565 HESSLER COLON THERAPY DEVICE
    K781923 NON-RETENTION ENEMA SYSTEM
    K770966 INTERNAL ECOLOGY MACHINE

    FEI Numbers

    This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.