K240595 is an FDA 510(k) clearance for the Utepreva Endometrial Sampler (UP01). This device is classified as a Brush, Endometrial (Class II - Special Controls, product code HFE).
Submitted by Utepreva, LLC (Jericho, US). The FDA issued a Cleared decision on August 14, 2024, 163 days after receiving the submission on March 4, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1100.
| 510(k) Number | K240595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2024 |
| Decision Date | August 14, 2024 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HFE - Brush, Endometrial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1100 |