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KPL — Colonic Irrigation System Class II

FDA Device Classification

Classification Details

Product Code
KPL
Device Class
Class II
Regulation Number
876.5220
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K201861gnali bociaBio Fluff SystemMarch 2, 2022
K180800colonic plusColonic Plus Regular, Small, and Straight Shape HydrokitJune 1, 2018
K152834colonplus equipments and speculums, s.lColonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with StopAugust 10, 2016
K150381quality medical supplyAQUA CLEANSESeptember 11, 2015
K131852transcendencias comerciales sl transcomHC-1 AND HC-1 CLASSICApril 17, 2014
K094022clearwater productsTHE WATER LILYJune 11, 2010
K071057tiller mind bodyCOLONIC & ENEMA NOZZLEOctober 5, 2007
K051344ultimate conceptsCOLONIC AND ENEMA NOZZLEAugust 18, 2005
K050992conmedcorpCONMED IRRIGATION NOZZLEJuly 14, 2005
K050112prime pacific health innovations corporationPRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117March 15, 2005
K033149ultimate conceptsULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEMMarch 23, 2004
K003720lifestream purfication systemsANGEL OF WATER COLON HYDROTHERAPY SYSTEMJune 27, 2002
K002102gentle colonicsGENTLE COLONICS IRRIGATION SYSTEMFebruary 6, 2002
K000031prime pacific health innovations corporationAQUANET, MODEL EC 2000September 10, 2001
K000388clearwater colon hydrotherapyCLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)August 8, 2000
K980868gentle colonicsGC IRRIGATORAugust 6, 1998
K970482srs intlTRANSCOM COLON HYDROTHERAPY MODEL HC-2000October 31, 1997
K973256colon therapeuticsJIMMY JOHN III RECTAL NOZZLESeptember 29, 1997
K972455colon therapeuticsJIMMY JOHN III RECTAL NOZZEL, MODEL CITSeptember 9, 1997
K962259tiller mind bodyLIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)August 29, 1996