876.4400 Hemorrhoidal ligator.§ 876.4400 Hemorrhoidal ligator.
(a) 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.
(b) 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.[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019]