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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR876.4370]
See Related Information on Gastroenterology-urology evacuator. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 876 -- GASTROENTEROLOGY-UROLOGY DEVICES

Subpart E--Surgical Devices

Sec. 876.4370 Gastroenterology-urology evacuator.

(a) Identification. A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.

(b) Classification. (1) Class II (special controls) for the gastroenterology-urology evacuator when other than manually powered. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 876.9.

(2) Class I for the gastroenterology-urology evacuator when manually powered. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 63 FR 59228, Nov. 3, 1998]

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