Brush, Endometrial
The Endometrial Brush is a sampling device introduced into the uterine cavity to collect endometrial cells by brushing the inner uterine wall, enabling cytological or histological examination for diagnostic purposes. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HFE, regulated under 21 CFR 884.1100, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HFE
- Device Class
- FDA class 2
- Regulation Number
- 884.1100
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240595 | Utepreva Endometrial Sampler (UP01) | Aug 14, 2024 | Substantially Equivalent | Utepreva, LLC |
| K170603 | Tao Brush I.U.M.C. Endometrial Sampler | May 24, 2017 | Substantially Equivalent | Cook Incorporated |
| K112763 | MATRIXBRUSH ENDOMETRIAL SAMPLER | Jun 18, 2012 | Substantially Equivalent | Post Oak Innovations, Inc. |
| K082066 | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | Nov 07, 2008 | Substantially Equivalent | Cook Urological, Inc. |
| K941298 | IUMC ENDOMETRIAL SAMPLER | Feb 13, 1995 | Substantially Equivalent | Cook Ob/Gyn |
| K911620 | STOVALL ENDOMETRIAL BRUSH | Jun 24, 1994 | Substantially Equivalent | Cook Ob/Gyn |
| K897070 | ENDOBRUSH(TM) DEVICE; OMNIBRUSH | Sep 10, 1990 | Substantially Equivalent | Intl. Cytobrush, Inc. |
| K881220 | ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER | Jun 14, 1988 | Substantially Equivalent | Laboratoire Ccd C/O Washington Regulatory Services |
| K843941 | ENDOCYTE | Feb 25, 1985 | Substantially Equivalent | Gyneco, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.