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510(k) K082066

TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER by Cook Urological, Inc. — Product Code HFE

K082066 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER". The FDA issued a decision of Substantially Equivalent on November 7, 2008. The device falls under product code HFE (Brush, Endometrial), a Class II device regulated under 21 CFR 884.1100. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2008
Date Received
July 22, 2008
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 Cook Urological, Inc.

  • K102141 — COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) (May 6, 2011)
  • K091767 — 3 WAY SILICONE FOLEY BALLOON CATHETER (October 9, 2009)
  • K082939 — COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 (September 3, 2009)
  • K082536 — COOK WIRE GUIDES (October 27, 2008)
  • K082319 — INJEKT FILIFORM INJECTION NEEDLE (September 25, 2008)
  • K080525 — COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W (April 17, 2008)
  • K073496 — OPTILITE HOLMIUM LASER FIBERS (January 23, 2008)
  • K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (November 20, 2007)
  • K061371 — SYDNEY IVF SPERM CRYOPRESERVATION BUFFER (August 17, 2006)
  • K060908 — SONOHYSTEROGRAPHY BIOPSY DEVICE (June 29, 2006)

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)
  • 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