21 C.F.R. § 876.4400

Current through May 31, 2024
Section 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 .

21 C.F.R. §876.4400

48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019