C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 876—GASTROENTEROLOGY-UROLOGY DEVICES › Subpart F—Therapeutic Devices

21 C.F.R. § 876.5980

Gastrointestinal tube and accessories

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(a) Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

(b) Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

[49 FR 573, Jan. 5, 1984, as amended at 65 FR 2317, Jan. 14, 2000; 65 FR 76932, Dec. 8, 2000; 84 FR 71814, Dec. 30, 2019]
Notes of Decisions
Cited in 1 case, 1990–1990 · leading case: Cruzan Ex Rel. Cruzan v. Dir., Missouri Dep't of Health, 497 U.S. 261 (1990).
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Cruzan Ex Rel. Cruzan v. Dir., Missouri Dep't of Health, 497 U.S. 261 (1990). · cites it 2× “C. § 1395u, p. 592 (1982 ed., Supp. V). The formulas are regulated by the federal Food and Drug Administration as "medical foods," see 21 U.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.