21 CFR 876.4370
§ 876.4370 Gastroenterology-urology evacuator.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 876.4370, § 876.4370 Gastroenterology-urology evacuator, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90303
- Permanent ID
ys:prov:90303@1- SHA-256
81a75df712a56515c96f717e2bf4628e5c241dbbb0b9690fe58474f26d54e4be
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.