Submission Details
| 510(k) Number | K240595 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Utepreva Endometrial Sampler (UP01)
Aug 2024
Decision
163d
Days
Class 2
Risk
About This 510(k) Submission
K240595 is an FDA 510(k) clearance for the Utepreva Endometrial Sampler (UP01), 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 review panel. Regulated under 21 CFR 884.1100.
Device Classification
| Product Code | HFE — Brush, Endometrial |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1100 |
Manufacturer
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