HFE
9 FDA 510(k) clearances · Product code
163 daysmedian time to decision
1170 days90th percentile
9clearances measured
FDA profile
- Official device name
- Brush, Endometrial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1100
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1997: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Utepreva Endometrial Sampler (UP01) (K240595) | Utepreva, LLC | 2024-08-14 |
| Tao Brush I.U.M.C. Endometrial Sampler (K170603) | Cook Incorporated | 2017-05-24 |
| MATRIXBRUSH ENDOMETRIAL SAMPLER (K112763) | Post Oak Innovations, Inc. | 2012-06-18 |
| TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER (K082066) | Cook Urological, Inc. | 2008-11-07 |
| IUMC ENDOMETRIAL SAMPLER (K941298) | Cook Ob/Gyn | 1995-02-13 |
| STOVALL ENDOMETRIAL BRUSH (K911620) | Cook Ob/Gyn | 1994-06-24 |
| ENDOBRUSH(TM) DEVICE; OMNIBRUSH (K897070) | Intl. Cytobrush, Inc. | 1990-09-10 |
| ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER (K881220) | Laboratoire Ccd C/O Washington Regulatory Services | 1988-06-14 |
| ENDOCYTE (K843941) | Gyneco, Inc. | 1985-02-25 |
Track HFE automatically
Every clearance here is in the API, with alerts when new ones post.