FDA 510(k)

Utepreva Endometrial Sampler (UP01)

K-Number: K240595 · 2024-08-14

Decision Date2024-08-14

Product CodeHFE

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Utepreva Endometrial Sampler (UP01) is the device name listed in this FDA 510(k) record. The listed applicant is Utepreva, LLC. It received FDA 510(k) clearance on 2024-08-14 under 510(k) 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. The listed applicant is Utepreva, LLC. The 510(k) number is K240595.

When did Utepreva Endometrial Sampler (UP01) receive FDA 510(k) clearance?

Utepreva Endometrial Sampler (UP01) received FDA 510(k) clearance on 2024-08-14, under 510(k) number K240595.

Who is the listed applicant for Utepreva Endometrial Sampler (UP01)?

The FDA 510(k) record lists Utepreva, LLC as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170603Tao Brush I.U.M.C. Endometrial SamplerCook Incorporated

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.