21 CFR § 884.1100 - Endometrial brush.

---
identifier: "/us/cfr/t21/s884.1100"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 884.1100 - Endometrial brush."
title_number: 21
title_name: "Food and Drugs"
section_number: "884.1100"
section_name: "Endometrial brush."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "884"
part_name: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "45 FR 12684, Feb. 26, 1980, unless otherwise noted."
cfr_part: "884"
---


# 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.

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