FCD · Barium Enema Kit
Gastroenterology, Urology · 21 CFR 876.5210 · Class 1
Overview
| Product Code | FCD |
|---|---|
| Device Name | Barium Enema Kit |
| Regulation | 21 CFR 876.5210 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K934585 | PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL | Lafayette Pharmaceuticals, Inc. | Nov 3, 1993 | SESE |
| K864835 | TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* | Eisai U.S.A., Inc. | Feb 11, 1987 | SESE |
Top Applicants
- Eisai U.S.A., Inc. — 1 clearance
- Lafayette Pharmaceuticals, Inc. — 1 clearance
