FDA Product Code
FDA Product Code HFE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.1100
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240595 | Utepreva Endometrial Sampler (UP01) | Utepreva, LLC | 2024-08-14 | Traditional | PDF ↗ |
| K170603 | Tao Brush I.U.M.C. Endometrial Sampler | Cook Incorporated | 2017-05-24 | Traditional | PDF ↗ |
| K112763 | MATRIXBRUSH ENDOMETRIAL SAMPLER | Post Oak Innovations, Inc. | 2012-06-18 | Traditional | PDF ↗ |
| K082066 | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | Cook Urological, Inc. | 2008-11-07 | Traditional | PDF ↗ |
| K941298 | IUMC ENDOMETRIAL SAMPLER | Cook Ob/Gyn | 1995-02-13 | Traditional | PDF ↗ |
| K911620 | STOVALL ENDOMETRIAL BRUSH | Cook Ob/Gyn | 1994-06-24 | Traditional | PDF ↗ |
| K897070 | ENDOBRUSH(TM) DEVICE; OMNIBRUSH | Intl. Cytobrush, Inc. | 1990-09-10 | Traditional | PDF ↗ |
| K881220 | ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER | Laboratoire Ccd C/O Washington Regulatory Services | 1988-06-14 | Traditional | PDF ↗ |
| K843941 | ENDOCYTE | Gyneco, Inc. | 1985-02-25 | Traditional | PDF ↗ |
Product code HFE · Class II · Obstetrics/Gynecology. Data: openFDA.