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510(k) K170603

Tao Brush I.U.M.C. Endometrial Sampler by Cook Incorporated — Product Code HFE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2017
Date Received
March 1, 2017
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

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Other clearances for product code HFE

  • K240595 — Utepreva Endometrial Sampler (UP01) (August 14, 2024)
  • 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)