HFE · Brush, Endometrial
Obstetrics/Gynecology · 21 CFR 884.1100 · Class 2
Overview
| Product Code | HFE |
|---|---|
| Device Name | Brush, Endometrial |
| Regulation | 21 CFR 884.1100 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 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 | Utepreva Endometrial Sampler (UP01) | Utepreva, LLC | Aug 14, 2024 | SESE |
| K170603 | Tao Brush I.U.M.C. Endometrial Sampler | Cook Incorporated | May 24, 2017 | SESE |
| K112763 | MATRIXBRUSH ENDOMETRIAL SAMPLER | Post Oak Innovations, Inc. | Jun 18, 2012 | SESE |
| K082066 | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | Cook Urological, Inc. | Nov 7, 2008 | SESE |
| K941298 | IUMC ENDOMETRIAL SAMPLER | Cook Ob/Gyn | Feb 13, 1995 | SESE |
| K911620 | STOVALL ENDOMETRIAL BRUSH | Cook Ob/Gyn | Jun 24, 1994 | SESE |
| K897070 | ENDOBRUSH(TM) DEVICE; OMNIBRUSH | Intl. Cytobrush, Inc. | Sep 10, 1990 | SESE |
| K881220 | ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER | Laboratoire Ccd C/O Washington Regulatory Services | Jun 14, 1988 | SESE |
| K843941 | 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
