Utepreva Endometrial Sampler (UP01)
FDA 510(k) K240595 · Utepreva, LLC
510(k) numberK240595
Submission
- Device name
- Utepreva Endometrial Sampler (UP01)
- Applicant
- Utepreva, LLC
Jericho, NY, US - Received
- March 4, 2024
- Decision date
- August 14, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HFE – Brush, Endometrial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1100
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170603 | Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional | Cook Incorporated | 05/24/2017SE |
| K112763 | Matrixbrush Endometrial SamplerHFE · Traditional | Post Oak Innovations, Inc. | 06/18/2012SE |
| K082066 | Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional | Cook Urological, Inc. | 11/07/2008SE |
| K941298 | Iumc Endometrial SamplerHFE · Traditional | Cook Ob/Gyn | 02/13/1995SE |
| K911620 | Stovall Endometrial BrushHFE · Traditional | Cook Ob/Gyn | 06/24/1994SE |
| K897070 | Endobrush(Tm) Device; OmnibrushHFE · Traditional | Intl. Cytobrush, Inc. | 09/10/1990SE |
| K881220 | Endocyte, Disposable Endometrial SamplerHFE · Traditional | Laboratoire Ccd C/O Washington Regulatory Services | 06/14/1988SE |
| K843941 | EndocyteHFE · Traditional | Gyneco, Inc. | 02/25/1985SE |
Questions and answers
When was Utepreva Endometrial Sampler (UP01) cleared by the FDA?
Utepreva Endometrial Sampler (UP01) (K240595) received a 510(k) decision of Substantially Equivalent on August 14, 2024, 163 days after the submission was received.
What is the product code of K240595?
The FDA product code is HFE – Brush, Endometrial, a Class II (moderate risk) device regulated under 21 CFR 884.1100.