Utepreva Endometrial Sampler (UP01)
K-Number: K240595 · 2024-08-14
ApplicantUtepreva, LLC
Decision Date2024-08-14
Product CodeHFE
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Utepreva Endometrial Sampler (UP01) is a medical device manufactured by Utepreva, LLC. It received FDA 510(k) clearance on 2024-08-14 under approval number K240595. The device is classified under product code HFE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Utepreva Endometrial Sampler (UP01)?
Utepreva Endometrial Sampler (UP01) is a medical device that received FDA 510(k) clearance on 2024-08-14. It is manufactured by Utepreva, LLC. The 510(k) number is K240595.
When was Utepreva Endometrial Sampler (UP01) approved by the FDA?
Utepreva Endometrial Sampler (UP01) received FDA 510(k) clearance on 2024-08-14, under approval number K240595.
What company makes Utepreva Endometrial Sampler (UP01)?
Utepreva Endometrial Sampler (UP01) is manufactured by Utepreva, LLC.
What is the FDA product code for Utepreva Endometrial Sampler (UP01)?
The FDA product code for Utepreva Endometrial Sampler (UP01) is HFE.
Related Devices (Code: HFE)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.