Home / 510(k) Clearances / K843941

510(k) K843941

ENDOCYTE by Gyneco, Inc. — Product Code HFE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1985
Date Received
October 9, 1984
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 Gyneco, Inc.

  • K861409 — SYNCARE TEMPORARY CARDIAC PACING WIRE (May 5, 1986)
  • K853216 — MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 (April 2, 1986)
  • K852357 — GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP (July 5, 1985)
  • K841275 — FINE NEEDLE ASPIRATION DEVICE (August 17, 1984)

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)
  • K897070 — ENDOBRUSH(TM) DEVICE; OMNIBRUSH (September 10, 1990)
  • K881220 — ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER (June 14, 1988)