Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES
/ Subpart E - Surgical Devices / § 876.4270 Colostomy rod.
§ 876.4270 Colostomy rod.
(a) Identification. A colostomy rod is a device used during the loop colostomy procedure. A loop of colon is surgically brought out through the abdominal wall and the stiff colostomy rod is placed through the loop temporarily to keep the colon from slipping back through the surgical opening.
(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.