---
kind: "section"
citation: "21 C.F.R. § 876.4370"
title: "21"
number: "876.4370"
heading: "Gastroenterology-urology evacuator."
url: "https://uscodex.org/cfr/21/876.4370"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 876.9](/cfr/21/876.9.md).
  - (2) **Class I for the gastroenterology-urology evacuator when manually powered.** The device subject to this [paragraph (b)(2)](#b-2) is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter.

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

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