21 CFR 876.5210 - Enema kit.

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§ 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]

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United States Code

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 876 after this date.

  • 2016-07-13; vol. 81 # 134 - Wednesday, July 13, 2016
    1. 81 FR 45229 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective July 13, 2016. The classification was applicable on June 3, 2016.
      21 CFR Part 876
The section you are viewing is cited by the following CFR sections.

Title 21 published on 2015-12-03.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2016-07-13; vol. 81 # 134 - Wednesday, July 13, 2016
    1. 81 FR 45229 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective July 13, 2016. The classification was applicable on June 3, 2016.
      21 CFR Part 876