HFE — Brush, Endometrial Class II
FDA Device Classification
Classification Details
- Product Code
- HFE
- Device Class
- Class II
- Regulation Number
- 884.1100
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K240595 | utepreva | Utepreva Endometrial Sampler (UP01) | August 14, 2024 |
| K170603 | cook incorporated | Tao Brush I.U.M.C. Endometrial Sampler | May 24, 2017 |
| K112763 | post oak innovations | MATRIXBRUSH ENDOMETRIAL SAMPLER | June 18, 2012 |
| K082066 | cook urological | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | November 7, 2008 |
| K941298 | cook ob/gyn | IUMC ENDOMETRIAL SAMPLER | February 13, 1995 |
| K911620 | cook ob/gyn | STOVALL ENDOMETRIAL BRUSH | June 24, 1994 |
| K897070 | intl. cytobrush | ENDOBRUSH(TM) DEVICE; OMNIBRUSH | September 10, 1990 |
| K881220 | laboratoire ccd c/o washington regulatory services | ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER | June 14, 1988 |
| K843941 | gyneco | ENDOCYTE | February 25, 1985 |