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510(k) Data Aggregation

    K Number
    K201861
    Device Name
    Bio Fluff System
    Manufacturer
    Gnali Bocia S.R.L.
    Date Cleared
    2022-03-02

    (604 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Product Code :

    KPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bio Fluff System is intended for colon cleansing to remove fecal residues when medically indicated, such as before radiological or endoscopic examination.
    Device Description
    The Bio Fluff System is intended to instill water through a disposable speculum into the colon. Intestinal Cleansing is carried out by inserting water in the patient's rectum at controlled temperature and pressure through the disposable specula. This action allows the cleaning of the lower tract of the colon. The Bio Fluff System comprises: - different models of the Bio Fluff device: - HT model, for professional use, - HTP model, portable version of HT model, - associated components: - disposable HT specula for both Bio Fluff model HT and Bio Fluff model HTP.
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    K Number
    K180800
    Device Name
    Colonic Plus Regular, Small, and Straight Shape Hydrokit
    Manufacturer
    Colonic Plus
    Date Cleared
    2018-06-01

    (66 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Product Code :

    KPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use of this device is restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.
    Device Description
    The Colonic Plus Regular, Small and Straight shape Hydrokits is a plastic, non-sterile, single use product colonic irrigation system that is used as an accessory with lower bowel Colonic irrigation systems intended to instill water into the colon through a nozzle inserted 2" 3" into the rectum to evacuate the contents of the lower colon.
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    K Number
    K152834
    Device Name
    Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
    Manufacturer
    COLONPLUS EQUIPMENTS & SPECULUMS, S.L.
    Date Cleared
    2016-08-10

    (316 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Product Code :

    KPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
    Device Description
    The disposable rectal speculum is a non-metal (Polypropylene) device used to introduce water into the colon and dispose waste from the colon during a colonic irrigation procedure.
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    K Number
    K150381
    Device Name
    AQUA CLEANSE
    Manufacturer
    QUALITY MEDICAL SUPPLY, INC
    Date Cleared
    2015-09-11

    (205 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Product Code :

    KPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THIS DEVICE IS INTENDED FOR COLON CLEANSING WHEN MEDICALLY INDICATED. SUCH AS BEFORE RADIOLOGICAL OR ENDOSCOPIC EXAMINATION.
    Device Description
    The proposed device "Aqua Cleanse" is for colon cleansing when medically indicated such as before radiological or endoscopic examination. It introduces water at a comfortable temperature into the large intestine. It fills and empties water into and out of the colon thus cleansing it of its contents. The device is equipped with a pressure regulated safety system; a self-contained cleaning system, and flow regulator. lt is used with the accessory, disposable rectal speculum kits. The associated disposable kit is intended to introduce water into the colon through a speculum inserted into the rectum to assist with the evacuation of the contents of the lower colon. This is a single-use only kit.
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    K Number
    K131852
    Device Name
    HC-1 AND HC-1 CLASSIC
    Manufacturer
    TRANSCENDENCIAS COMERCIALES SL TRANSCOM
    Date Cleared
    2014-04-17

    (300 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Product Code :

    KPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use of this device is restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.
    Device Description
    The HC-1 and HC-1 Classic proposed device is a device for colon cleaning. It introduces water at a comfortable temperature into the large intestine. It automatically fills and empties water into and out of the colon thus cleansing it of its contents when medically indicated such as before radiological or endoscopic examination. It is hygienic, painless and odorless. The device is equipped with an automatic pressure safety system; integrated disinfectant container, flow regulator and a 3-way manifold. It is supplied with disposable probe/hose assemblies for single-use during colonic hydrotherapy. The HYDROKIT is a colonic irrigation system intended to instill water into the colon through a nozzle inserted into the rectum to evacuate the contents of the lower colon.
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    K Number
    K094022
    Device Name
    THE WATER LILY
    Manufacturer
    CLEARWATER PRODUCTS, LLC
    Date Cleared
    2010-06-11

    (163 days)

    Product Code
    KPL, DEV
    Regulation Number
    876.5220
    Why did this record match?
    Product Code :

    KPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Water Lily The is indicated for colon cleansing when medically indicated, such as before radiological or endoscopic examination.
    Device Description
    The Water Lily 10 is a professional colon hydrotherapy system for use when medically indicated. It introduces filtered water at a comfortable temperature into the large intestine, thus cleansing the colon of its contents. Water temperature is controlled by means of a mixing valve; flow is controlled by one switch operated by the user. The system is manually sanitized prior to each use with a suitable broad spectrum disinfectant (not included). The system includes disposable tubing and a sterile, disposable rectal nozzle intended for single use only (ConMed Corporation K050992).
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    K Number
    K071057
    Device Name
    COLONIC & ENEMA NOZZLE
    Manufacturer
    TILLER MIND BODY, INC.
    Date Cleared
    2007-10-05

    (172 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Product Code :

    KPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Libbe Colonic Nozzle is to be used as the Device/Nozzle inserted into the rectum when used with the LIBBE Lower Bowel Evacuation System. The Device/Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examination.
    Device Description
    The LIBBE Colonic Nozzle device is a plastic, non-sterile, single use product for use as an accessory with lower bowel evacuation systems or enema kits. The Device/Nozzle is intended to be inserted two to three inches into the rectum for instilling water into the colon region. The LIBBE Colonic Nozzle is designed as a one-piece, injection molded, medical grade plastic accessory. The nozzle has an open tip with a slight bulb shape that has two small holes in its wall. The proximal end of the nozzle has a barbed fitting for attachment to plastic tubing from the colonic irrigation, or enema, system.
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    K Number
    K051344
    Device Name
    COLONIC AND ENEMA NOZZLE
    Manufacturer
    ULTIMATE CONCEPTS, INC.
    Date Cleared
    2005-08-18

    (87 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Product Code :

    KPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Colonic Nozzle is to be used as an attachment to gravity fed colonic systems for cleansing when medically indicated such as before radiological or endoscopic examination.
    Device Description
    This Colonic nozzle is made of medical grade tubing, has an opening on one end. The other end is sealed with a small hole in the middle and has two holes on the sides at the same end.
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    K Number
    K050992
    Device Name
    CONMED IRRIGATION NOZZLE
    Manufacturer
    CONMED CORP.
    Date Cleared
    2005-07-14

    (86 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Product Code :

    KPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ConMed Irrigation Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
    Device Description
    The device is sterile, for single-use and is intended for use as an accessory with The device is stome, for clingie nomercial distribution and acts as a nozzle when inserted into a patient's recturn to direct water into and cleanse the lower colon when medically indicated, such as before radiological or endoscopic examination. The nozzle is designed as a one-piece, injection molded plastic handpiece having a slight curvature at the end intended for insertion into the rectum. At the opposite end the device has a barbed fitting for attachment to the tubing from the colonic irrigation system. Several tip configurations are made available to provide options for the clinician.
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    K Number
    K050112
    Device Name
    PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
    Manufacturer
    PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
    Date Cleared
    2005-03-15

    (56 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Product Code :

    KPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.
    Device Description
    The Pro-Fit™ disposable rectal speculum is a non-metal (Polyethelene) device used to introduce water into the colon and dispose waste from the colon during a colonic irrigation procedure.
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