Title 21: Food and Drugs
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/ PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES
/ Subpart E - Surgical Devices / § 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.