Colonic Irrigation System

FDA product code KPL · 38 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5220
Review panel: GU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-08-18 – 2022-03-02

KPL 2022-03-02

Bio Fluff System

Applicant Gnali Bocia S.R.L.

K number K201861

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KPL 2018-06-01

Colonic Plus Regular, Small, and Straight Shape Hydrokit

Applicant Colonic Plus

K number K180800

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KPL 2016-08-10

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

Applicant Colonplus Equipments & Speculums, S.L.

K number K152834

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KPL 2010-06-11

THE WATER LILY

Applicant Clearwater Products, LLC

K number K094022

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KPL 2007-10-05

COLONIC & ENEMA NOZZLE

Applicant Tiller Mind Body, Inc.

K number K071057

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KPL 2005-08-18

COLONIC AND ENEMA NOZZLE

Applicant Ultimate Concepts, Inc.

K number K051344

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KPL 2005-07-14

CONMED IRRIGATION NOZZLE

Applicant Conmedcorp

K number K050992

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KPL 2005-03-15

PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117

Applicant Prime Pacific Health Innovations Corporation

K number K050112

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KPL 2004-03-23

ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM

Applicant Ultimate Concepts, Inc.

K number K033149

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KPL 2002-06-27

ANGEL OF WATER COLON HYDROTHERAPY SYSTEM

Applicant Lifestream Purfication Systems, LLC

K number K003720

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KPL 2002-02-06

GENTLE COLONICS IRRIGATION SYSTEM

Applicant Gentle Colonics, Inc.

K number K002102

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KPL 2001-09-10

AQUANET, MODEL EC 2000

Applicant Prime Pacific Health Innovations Corporation

K number K000031

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KPL 2000-08-08

CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)

Applicant Clearwater Colon Hydrotherapy, Inc.

K number K000388

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KPL 1998-08-06

GC IRRIGATOR

Applicant Gentle Colonics, Inc.

K number K980868

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KPL 1997-10-31

TRANSCOM COLON HYDROTHERAPY MODEL HC-2000

Applicant Srs Intl.

K number K970482

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KPL 1997-09-29

JIMMY JOHN III RECTAL NOZZLE

Applicant Colon Therapeutics

K number K973256

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KPL 1997-09-09

JIMMY JOHN III RECTAL NOZZEL, MODEL CIT

Applicant Colon Therapeutics

K number K972455

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KPL 1996-08-29

LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)

Applicant Tiller Mind Body, Inc.

K number K962259

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KPL 1996-06-26

CLEARWATER COLON HYDROTHERAPY MODEL PPC-101

Applicant Clearwater Colon Hydrotherapy, Inc.

K number K942867

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KPL 1995-10-12

LOWER BOWEL EVACUATION SYSTEM

Applicant Tiller Mind Body, Inc.

K number K941279

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KPL 1990-12-24

SYSTEMS FLOW 2000

Applicant Universal Hydrotech, Inc.

K number K902993

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KPL 1989-10-13

ENEMA KIT

Applicant Ledins Herbal Healing Systems

K number K894209

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KPL 1989-08-03

HYDRO-SAN COLONIC IRRIGATION SYSTEM

Applicant Specialty Health Products, Inc.

K number K891585

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KPL 1989-06-22

CUFF SPECULUM

Applicant Mountain Medical Equipment, Inc.

K number K893531

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KPL 1989-03-10

BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002

Applicant Medical Imaging Systems, Inc.

K number K885092

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KPL 1988-07-20

JIMMY JOHN III

Applicant Colon Therapeutics

K number K881720

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KPL 1987-10-14

MODIFIED RECTAL NOZZLE

Applicant Colon Therapeutics

K number K873948

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KPL 1987-06-18

DOTOLO COLON HYDROTHERAPY INSTRUMENT

Applicant Dotolo Research Corp. C/O Keller and Heckman

K number K870534

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KPL 1987-03-17

JIMMY JOHN III, COLONIC IRRIGATION SYSTEM

Applicant Colon Therapeutics

K number K870376

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KPL 1987-03-17

MODIFIED JIMMY JOHN III

Applicant Colon Therapeutics

K number K870127

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KPL 1986-10-16

HYDRO-CLENZ UNIT

Applicant Atlantic Health Group

K number K863539

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KPL 1986-05-15

JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION)

Applicant Colon Therapeutics

K number K860943

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KPL 1984-10-24

JIMMY JOHN III

Applicant Colon Therapeutics

K number K842083

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KPL 1984-07-17

COLON IRRIGATION UNIT

Applicant Colenz Co.

K number K840613

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KPL 1980-12-31

SARNS INFANT ARTERIAL BUBBLE SENSOR

Applicant 3M Health Care, Sarns

K number K803105

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KPL 1980-06-26

HESSLER COLON THERAPY DEVICE

Applicant Hessler Mfg. Co.

K number K800565

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KPL 1979-08-03

NON-RETENTION ENEMA SYSTEM

Applicant Hudson Kendale Assoc., Inc.

K number K781923

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KPL 1977-08-18

INTERNAL ECOLOGY MACHINE

Applicant Holistic Equipment, Inc.

K number K770966

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