510(k) K240595
- Device
- Utepreva Endometrial Sampler (UP01)
- Applicant
- Utepreva, LLC
- 510(k) number
- K240595
- Product code
- HFE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-14
- Date received
- 2024-03-04
- Regulation
- 884.1100
- Classification name
- Brush, Endometrial
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Zanetta Malanowska-Stega
- Address
- 100 Jericho Quadrangle Suite 333 Jericho NY US 11753 11753
FDA Registration Numbers#
- 1216677
- 1825146
- 2246552
- 1820334
- 1319639
- 3017262662
- 3008573567
- 3009770819
- 1422634
Source Documents#
Other 510(k) Records For Product Code HFE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170603 | Tao Brush I.U.M.C. Endometrial Sampler | Cook Incorporated | 2017-05-24 |
| K112763 | MATRIXBRUSH ENDOMETRIAL SAMPLER | Post Oak Innovations, Inc. | 2012-06-18 |
| K082066 | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | Cook Urological, Inc. | 2008-11-07 |
| K941298 | IUMC ENDOMETRIAL SAMPLER | Cook Ob/Gyn | 1995-02-13 |
| K911620 | STOVALL ENDOMETRIAL BRUSH | Cook Ob/Gyn | 1994-06-24 |
| K897070 | ENDOBRUSH(TM) DEVICE; OMNIBRUSH | Intl. Cytobrush, Inc. | 1990-09-10 |
| K881220 | ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER | Laboratoire Ccd C/O Washington Regulatory Services | 1988-06-14 |
| K843941 | ENDOCYTE | Gyneco, Inc. | 1985-02-25 |