§876.4400. Hemorrhoidal ligator.
21 C.F.R. § 876.4400
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, 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 71813, 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 71813, Dec. 30, 2019]