Product Code: FCE FDA class 1 21 CFR 876.5210

Enema Kit

Gastroenterology, Urology

The Enema Kit (product code FCE) is a convenience kit containing supplies needed to administer an enema, typically for bowel cleansing or therapeutic purposes. It is an FDA Class 1 device (lowest risk) established under the May 20, 1997 Convenience Kits Interim Regulatory Guidance; kits meeting all criteria in that guidance are under enforcement discretion and do not require a 510(k). It is regulated under 21 CFR 876.5210 in the Gastroenterology and Urology specialty. This device is GMP exempt.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FCE
Device Class: FDA class 1
Regulation Number: 876.5210
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 30 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K974042	AMSURE CLEANSING ENEMA SET	Dec 19, 1997	Substantially Equivalent	Amsino Intl., Inc.
K931896	PRO-FLO SYSTEM	Aug 26, 1993	Substantially Equivalent	Lafayette Pharmacal, Inc.
K922398	4 SURE TM ENEMA BAG SET	Jun 17, 1993	Unknown	Boston Pacific Medical, Inc.
K913620	ENEMA KIT	Nov 01, 1991	Unknown	York County Blind Center
K904534	ENEMA BULB	Dec 21, 1990	Substantially Equivalent	R.A.C., Inc.
K901182	ENEMA BAG SET	Jun 28, 1990	Unknown	Orion Life Systems, Inc.
K901179	ENEMA BUCKET SET	Jun 28, 1990	Unknown	Orion Life Systems, Inc.
K900848	ENEMA KIT 'STRAIGHT' DESIGN	Apr 13, 1990	Substantially Equivalent	Custom Medical Products, Ltd.
K900847	ENEMA KIT 'Y' DESIGN	Apr 13, 1990	Substantially Equivalent	Custom Medical Products, Ltd.
K881218	GENT-L-KARE CLEANSING ENEMA SET	Jul 28, 1988	Substantially Equivalent	Geneva Laboratories, Inc.
K880337	MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700	Apr 14, 1988	Substantially Equivalent	Plasco, Inc.
K872992	SPS SUSPENSION ENEMA KIT	Sep 17, 1987	Substantially Equivalent	Carolina Medical Products Co.
K870796	MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY	Apr 01, 1987	Substantially Equivalent	Plasco, Inc.
K870019	THE LAHR BALLOON	Apr 01, 1987	Substantially Equivalent	Plasco, Inc.
K843792	VAN JON SUPER CLYSTER(KIT, ENEMA	Apr 22, 1985	Substantially Equivalent	Van Jon Co.
K842130	G.I. CLEANSING KIT	Aug 08, 1984	Substantially Equivalent	Mmi, Inc.
K832960	SHUFFIELD TECH ENEMA TIP	Jan 03, 1984	Substantially Equivalent	Shuffield Tech Co.
K833860	TUCK-TITE COLON FLUID RETAINER	Dec 27, 1983	Substantially Equivalent	Clayton Medical Products, Inc.
K800961	ENEMA CONTAINER DISP. FOR EMEMA ADMIN.	May 14, 1980	Substantially Equivalent	The Healthcare Group Laboratories, Inc.
K800960	1500 ML DISPOSABLE ENEMA CONTAINER(1110)	May 14, 1980	Substantially Equivalent	The Healthcare Group Laboratories, Inc.
K800959	LARGE VOLUME ENEMA CONTAINER DISPOSABLE	May 14, 1980	Substantially Equivalent	The Healthcare Group Laboratories, Inc.
K791863	MAC LEE ENEMAD	Oct 02, 1979	Substantially Equivalent	Mac Lee Medical Products
K790535	CLAYTON COLON CLEANSING KIT	Jun 07, 1979	Substantially Equivalent	Clayton Medical Products, Inc.
K790005	ADMINISTRATION SET, ENEMA	Jan 17, 1979	Substantially Equivalent	Kelsar Corp.
K780877	ENEMA BAG	Aug 14, 1978	Substantially Equivalent	Abco Dealers, Inc.
K780613	ENEMA, PHOSPHATE	Jun 02, 1978	Substantially Equivalent	Abco Dealers, Inc.
K771792	ENEMA SET	Oct 20, 1977	Substantially Equivalent	Chase Mfg. Co.
K770300	COLON IRRIGATION DEV.,COLON-A-SUN COLONI	Mar 30, 1977	Substantially Equivalent	Sun Product Dist., Inc.
K760777	COLON-X	Jan 13, 1977	Substantially Equivalent	Carlton Hygienics, Inc.
K761167	ENEMA KIT	Dec 09, 1976	Substantially Equivalent	American Hospital Supply Corp.