---
kind: "section"
citation: "21 C.F.R. § 876.5100"
title: "21"
number: "876.5100"
heading: "Suprapubic catheter accessories."
url: "https://uscodex.org/cfr/21/876.5100"
---

# §876.5100. Suprapubic catheter accessories.

- (a) **Identification.** Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath.
- (b) **Classification.** Class I (general controls). 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 the limitations in [§ 876.9](/cfr/21/876.9.md).

## Notes

### Amendments

[84 FR 14870, Apr. 12, 2019]

### 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

[84 FR 14870, Apr. 12, 2019]