Enema Kit

FDA product code FCE · Class I (low risk) · 21 CFR 876.5210 · Gastroenterology, Urology

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

30510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K974042Amsure Cleansing Enema SetFCE · Traditional Amsino Intl., Inc.12/19/1997SE
K931896Pro-Flo SystemFCE · Traditional Lafayette Pharmacal, Inc.08/26/1993SE
K9223984 Sure TM Enema Bag SetFCE · Traditional Boston Pacific Medical, Inc.06/17/1993SEKD
K913620Enema KitFCE · Traditional York County Blind Center11/01/1991SESK
K904534Enema BulbFCE · Traditional R.A.C., Inc.12/21/1990SE
K901182Enema Bag SetFCE · Traditional Orion Life Systems, Inc.06/28/1990SESK
K901179Enema Bucket SetFCE · Traditional Orion Life Systems, Inc.06/28/1990SESK
K900848Enema Kit 'Straight' DesignFCE · Traditional Custom Medical Products, Ltd.04/13/1990SE
K900847Enema Kit 'Y' DesignFCE · Traditional Custom Medical Products, Ltd.04/13/1990SE
K881218Gent-L-Kare Cleansing Enema SetFCE · Traditional Geneva Laboratories, Inc.07/28/1988SE
K880337Macbick Disposable Barium Enema Syst 4800 & 4700FCE · Traditional Plasco, Inc.04/14/1988SE
K872992SPS Suspension Enema KitFCE · Traditional Carolina Medical Products Co.09/17/1987SE
K870796Macbick-Xl Basic Air Contast Barium Enema Deliv SyFCE · Traditional Plasco, Inc.04/01/1987SE
K870019The Lahr BalloonFCE · Traditional Plasco, Inc.04/01/1987SE
K843792Van Jon Super Clyster(Kit, EnemaFCE · Traditional Van Jon Co.04/22/1985SE
K842130G.I. Cleansing KitFCE · Traditional Mmi, Inc.08/08/1984SE
K832960Shuffield Tech Enema TipFCE · Traditional Shuffield Tech Co.01/03/1984SE
K833860Tuck-Tite Colon Fluid RetainerFCE · Traditional Clayton Medical Products, Inc.12/27/1983SE
K800961Enema Container Disp. for Emema Admin.FCE · Traditional The Healthcare Group Laboratories, Inc.05/14/1980SE
K8009601500 ML Disposable Enema CONTAINER(1110)FCE · Traditional The Healthcare Group Laboratories, Inc.05/14/1980SE
K800959Large Volume Enema Container DisposableFCE · Traditional The Healthcare Group Laboratories, Inc.05/14/1980SE
K791863Mac Lee EnemadFCE · Traditional Mac Lee Medical Products10/02/1979SE
K790535Clayton Colon Cleansing KitFCE · Traditional Clayton Medical Products, Inc.06/07/1979SE
K790005Administration Set, EnemaFCE · Traditional Kelsar Corp.01/17/1979SE
K780877Enema BagFCE · Traditional Abco Dealers, Inc.08/14/1978SE
K780613Enema, PhosphateFCE · Traditional Abco Dealers, Inc.06/02/1978SE
K771792Enema SetFCE · Traditional Chase Mfg. Co.10/20/1977SE
K770300Colon Irrigation Dev.,Colon-A-Sun ColoniFCE · Traditional Sun Product Dist., Inc.03/30/1977SE
K760777Colon-XFCE · Traditional Carlton Hygienics, Inc.01/13/1977SE
K761167Enema KitFCE · Traditional American Hospital Supply Corp.12/09/1976SE