---
kind: "section"
citation: "21 C.F.R. § 884.1100"
title: "21"
number: "884.1100"
heading: "Endometrial brush."
url: "https://uscodex.org/cfr/21/884.1100"
---

# §884.1100. Endometrial brush.

- (a) **Identification.** An endometrial brush is a device designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its surface. This device is used to study endometrial cytology (cells).
- (b) **Classification.** Class II. The special controls for this device are:
  - (1) **FDA's—**
    - (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
    - (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
  - (2) **Labeling—**
    - (i) **Indication—** Only to evaluate the endometrium, and
    - (ii) **Contraindications—** Pregnancy, history of uterine perforation, or a recent cesarean section, and
  - (3) **Design and testing—**
    - (i) The sampling component is covered within the vagina, and
    - (ii) **For adherence of the bristles and brush head.**

## Notes

### Amendments

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000]

### Authority

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

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

### Amendments

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000]