21 C.F.R. § 876.5895

Current through April 30, 2024
Section 876.5895 - Ostomy irrigator
(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 .

21 C.F.R. §876.5895

48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019