§876.5895. Ostomy irrigator.
21 C.F.R. § 876.5895
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.
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.
Notes, amendments, and revision history
Amendments
[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.
Amendments
[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019]