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510(k) K240595

Utepreva Endometrial Sampler (UP01) by Utepreva, LLC — Product Code HFE

K240595 is an FDA 510(k) premarket notification submitted by Utepreva, LLC for the device "Utepreva Endometrial Sampler (UP01)". The FDA issued a decision of Substantially Equivalent on August 14, 2024. The device falls under product code HFE (Brush, Endometrial), a Class II device regulated under 21 CFR 884.1100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2024
Date Received
March 4, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brush, Endometrial
Device Class
Class II
Regulation Number
884.1100
Review Panel
OB
Submission Type

Other clearances for product code HFE

  • K170603 — Tao Brush I.U.M.C. Endometrial Sampler (May 24, 2017)
  • K112763 — MATRIXBRUSH ENDOMETRIAL SAMPLER (June 18, 2012)
  • K082066 — TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER (November 7, 2008)
  • K941298 — IUMC ENDOMETRIAL SAMPLER (February 13, 1995)
  • K911620 — STOVALL ENDOMETRIAL BRUSH (June 24, 1994)
  • K897070 — ENDOBRUSH(TM) DEVICE; OMNIBRUSH (September 10, 1990)
  • K881220 — ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER (June 14, 1988)
  • K843941 — ENDOCYTE (February 25, 1985)

FDA data resources