Panels › Obstetrics/Gynecology › Product code HFE · Class 2
Brush, Endometrial
Regulation 884.1100
0510(k)s in 12 months (9 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in HFE
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Ob/Gyn | 2 | 1 |
| Cook Incorporated | 1 | 0 |
| Cook Urological, Inc. | 1 | 0 |
| Gyneco, Inc. | 1 | 0 |
| Intl. Cytobrush, Inc. | 1 | 0 |
| Laboratoire Ccd C/O Washington Regulatory Services | 1 | 0 |
| Post Oak Innovations, Inc. | 1 | 0 |
| Utepreva, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 14, 2024 | K240595 | Utepreva Endometrial Sampler (UP01) Utepreva, LLC | HFE |
| May 24, 2017 | K170603 | Tao Brush I.U.M.C. Endometrial Sampler Cook Incorporated | HFE |
| Jun 18, 2012 | K112763 | MATRIXBRUSH ENDOMETRIAL SAMPLER Post Oak Innovations, Inc. | HFE |
| Nov 7, 2008 | K082066 | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER Cook Urological, Inc. | HFE |
| Feb 13, 1995 | K941298 | IUMC ENDOMETRIAL SAMPLER Cook Ob/Gyn | HFE |
| Jun 24, 1994 | K911620 | STOVALL ENDOMETRIAL BRUSH Cook Ob/Gyn | HFE |
| Sep 10, 1990 | K897070 | ENDOBRUSH(TM) DEVICE; OMNIBRUSH Intl. Cytobrush, Inc. | HFE |
| Jun 14, 1988 | K881220 | ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER Laboratoire Ccd C/O Washington Regulatory Services | HFE |
| Feb 25, 1985 | K843941 | ENDOCYTE Gyneco, Inc. | HFE |
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