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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2009 | Cook OB/Gyn, Inc. Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL.
Used to obtain endometrial samples for Terminated |
HFE | K082066 K941298 |
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