FCE · Enema Kit
Gastroenterology, Urology · 21 CFR 876.5210 · Class 1
Overview
| Product Code | FCE |
|---|---|
| Device Name | Enema Kit |
| Regulation | 21 CFR 876.5210 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
| GMP Exempt | Yes |
Identification
An enema kit is a device intended to instill water or other fluids into the colon through a nozzle inserted into the rectum to promote evacuation of the contents of the lower colon. The device consists of a container for fluid connected to the nozzle either directly or via tubing. This device does not include the colonic irrigation system (§ 876.5220).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9. The device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 30)
Showing 20 most recent of 30 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974042 | AMSURE CLEANSING ENEMA SET | Amsino Intl., Inc. | Dec 19, 1997 | SESE |
| K931896 | PRO-FLO SYSTEM | Lafayette Pharmacal, Inc. | Aug 26, 1993 | SESE |
| K922398 | 4 SURE TM ENEMA BAG SET | Boston Pacific Medical, Inc. | Jun 17, 1993 | SEKD |
| K913620 | ENEMA KIT | York County Blind Center | Nov 1, 1991 | SESK |
| K904534 | ENEMA BULB | R.A.C., Inc. | Dec 21, 1990 | SESE |
| K901182 | ENEMA BAG SET | Orion Life Systems, Inc. | Jun 28, 1990 | SESK |
| K901179 | ENEMA BUCKET SET | Orion Life Systems, Inc. | Jun 28, 1990 | SESK |
| K900848 | ENEMA KIT 'STRAIGHT' DESIGN | Custom Medical Products, Ltd. | Apr 13, 1990 | SESE |
| K900847 | ENEMA KIT 'Y' DESIGN | Custom Medical Products, Ltd. | Apr 13, 1990 | SESE |
| K881218 | GENT-L-KARE CLEANSING ENEMA SET | Geneva Laboratories, Inc. | Jul 28, 1988 | SESE |
| K880337 | MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 | Plasco, Inc. | Apr 14, 1988 | SESE |
| K872992 | SPS SUSPENSION ENEMA KIT | Carolina Medical Products Co. | Sep 17, 1987 | SESE |
| K870796 | MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY | Plasco, Inc. | Apr 1, 1987 | SESE |
| K870019 | THE LAHR BALLOON | Plasco, Inc. | Apr 1, 1987 | SESE |
| K843792 | VAN JON SUPER CLYSTER(KIT, ENEMA | Van Jon Co. | Apr 22, 1985 | SESE |
| K842130 | G.I. CLEANSING KIT | Mmi, Inc. | Aug 8, 1984 | SESE |
| K832960 | SHUFFIELD TECH ENEMA TIP | Shuffield Tech Co. | Jan 3, 1984 | SESE |
| K833860 | TUCK-TITE COLON FLUID RETAINER | Clayton Medical Products, Inc. | Dec 27, 1983 | SESE |
| K800961 | ENEMA CONTAINER DISP. FOR EMEMA ADMIN. | The Healthcare Group Laboratories, Inc. | May 14, 1980 | SESE |
| K800960 | 1500 ML DISPOSABLE ENEMA CONTAINER(1110) | The Healthcare Group Laboratories, Inc. | May 14, 1980 | SESE |
Top Applicants
- Plasco, Inc. — 3 clearances
- The Healthcare Group Laboratories, Inc. — 3 clearances
- Abco Dealers, Inc. — 2 clearances
- Clayton Medical Products, Inc. — 2 clearances
- Custom Medical Products, Ltd. — 2 clearances
