§ 876.5895. Ostomy irrigator.
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/us/cfr/t21/s§ 876.5895·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.
(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. [48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019]