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510(k) K112763

MATRIXBRUSH ENDOMETRIAL SAMPLER by Post Oak Innovations, Inc. — Product Code HFE

K112763 is an FDA 510(k) premarket notification submitted by Post Oak Innovations, Inc. for the device "MATRIXBRUSH ENDOMETRIAL SAMPLER". The FDA issued a decision of Substantially Equivalent on June 18, 2012. 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
June 18, 2012
Date Received
September 22, 2011
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

  • K240595 — Utepreva Endometrial Sampler (UP01) (August 14, 2024)
  • K170603 — Tao Brush I.U.M.C. Endometrial Sampler (May 24, 2017)
  • 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