{"data":{"id":"us/21-cfr-876.5895","jurisdiction":"us","citation":"21 CFR 876.5895","heading":"Ostomy irrigator.","body":"(a) Identification. An ostomy irrigator is a device that consists of a container for fluid, tubing with a cone-shaped tip or a soft and flexible catheter with a retention shield and that is used to wash out the colon through a colostomy, a surgically created opening of the colon on the surface of the body.\n(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 876—GASTROENTEROLOGY-UROLOGY DEVICES","Subpart F—Therapeutic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"9172825aab60eefa8ffbee455ec9b7cf7fe747e438d786693d8c9b3a362c50be","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-876.5885","next":"us/21-cfr-876.5900"},"notice":"GroundRules: Original legal text. Not legal advice."}