Section 876.5210 - Enema kit(a)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 ).(b)Classification. 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 system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.48 FR 53023, Nov. 23, 1963, as amended at 65 FR 2317 , Jan. 14, 2000