Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart B — Obstetrical and Gynecological Diagnostic Devices](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices) → [21 CFR 884.1100](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1100) → HFE — Brush, Endometrial

# HFE · Brush, Endometrial

_Obstetrics/Gynecology · 21 CFR 884.1100 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFE

## Overview

- **Product Code:** HFE
- **Device Name:** Brush, Endometrial
- **Regulation:** [21 CFR 884.1100](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1100)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **3rd-party reviewable:** yes

## 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).

## Classification Rationale

Class II. The special controls for this device are:

## Special Controls

*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.

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K240595](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFE/K240595.md) | Utepreva Endometrial Sampler (UP01) | Utepreva, LLC | Aug 14, 2024 | SESE |
| [K170603](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFE/K170603.md) | Tao Brush I.U.M.C. Endometrial Sampler | Cook Incorporated | May 24, 2017 | SESE |
| [K112763](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFE/K112763.md) | MATRIXBRUSH ENDOMETRIAL SAMPLER | Post Oak Innovations, Inc. | Jun 18, 2012 | SESE |
| [K082066](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFE/K082066.md) | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | Cook Urological, Inc. | Nov 7, 2008 | SESE |
| [K941298](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFE/K941298.md) | IUMC ENDOMETRIAL SAMPLER | Cook Ob/Gyn | Feb 13, 1995 | SESE |
| [K911620](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFE/K911620.md) | STOVALL ENDOMETRIAL BRUSH | Cook Ob/Gyn | Jun 24, 1994 | SESE |
| [K897070](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFE/K897070.md) | ENDOBRUSH(TM) DEVICE; OMNIBRUSH | Intl. Cytobrush, Inc. | Sep 10, 1990 | SESE |
| [K881220](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFE/K881220.md) | ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER | Laboratoire Ccd C/O Washington Regulatory Services | Jun 14, 1988 | SESE |
| [K843941](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFE/K843941.md) | ENDOCYTE | Gyneco, Inc. | Feb 25, 1985 | SESE |

## Top Applicants

- Cook Ob/Gyn — 2 clearances
- Cook Incorporated — 1 clearance
- Cook Urological, Inc. — 1 clearance
- Gyneco, Inc. — 1 clearance
- Intl. Cytobrush, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFE](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFE)

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