21 C.F.R. · Food and Drugs
21 C.F.R. § 876.4400

Hemorrhoidal ligator.

Title 21 C.F.R. ● ACTIVE Primary Source
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21 C.F.R. § 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]

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The regulatory text of 21 C.F.R. § 876.4400 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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