Utepreva Endometrial Sampler (UP01)— 510(k) K240595

Name: FDA 510(k) clearance K240595
Creator: U.S. Food and Drug Administration
Published: 2024-08-14

Substantially Equivalent

Utepreva, LLC

FDA 510(k) clearance K240595 for Utepreva Endometrial Sampler (UP01), Substantially Equivalent on 2024-08-14. Applicant: Utepreva, LLC. Device class: 2.

Clearance details

Applicant: Utepreva, LLC
Product code: Code HFE
Device class: Class 2
Regulation: 21 CFR 884.1100
Advisory panel: Obstetrics/Gynecology
Date received: 2024-03-04
Decision date: 2024-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jericho, NY, US

Download summary PDF View on FDA.gov ↗

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K941298 — IUMC ENDOMETRIAL SAMPLER1995-02-13
K911620 — STOVALL ENDOMETRIAL BRUSH1994-06-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.