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510(k) K897070

ENDOBRUSH(TM) DEVICE; OMNIBRUSH by Intl. Cytobrush, Inc. — Product Code HFE

K897070 is an FDA 510(k) premarket notification submitted by Intl. Cytobrush, Inc. for the device "ENDOBRUSH(TM) DEVICE; OMNIBRUSH". The FDA issued a decision of Substantially Equivalent on September 10, 1990. The device falls under product code HFE (Brush, Endometrial), a Class II device regulated under 21 CFR 884.1100. Intl. Cytobrush, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1990
Date Received
December 22, 1989
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 by Intl. Cytobrush, Inc.

  • K895675 — PAP SMEAR TRAY (December 11, 1989)
  • K862322 — CHLAMYDIA KIT, STD KIT (July 7, 1986)
  • K861389 — PAP SMEAR KIT (May 2, 1986)

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)
  • 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)
  • K881220 — ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER (June 14, 1988)
  • K843941 — ENDOCYTE (February 25, 1985)

FDA data resources