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510(k) K941298

IUMC ENDOMETRIAL SAMPLER by Cook Ob/Gyn — Product Code HFE

K941298 is an FDA 510(k) premarket notification submitted by Cook Ob/Gyn for the device "IUMC ENDOMETRIAL SAMPLER". The FDA issued a decision of Substantially Equivalent on February 13, 1995. The device falls under product code HFE (Brush, Endometrial), a Class II device regulated under 21 CFR 884.1100. Cook Ob/Gyn has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1995
Date Received
March 17, 1994
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 Ob/Gyn

  • K062438 — BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 (October 27, 2006)
  • K030441 — SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT (August 29, 2003)
  • K023850 — SYDNEY IVF EMBRYO BIOPSY MEDIUM (January 22, 2003)
  • K013597 — TAMPONADE UTERINE BALLOON CATHETER SET (April 17, 2002)
  • K002385 — COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILI (September 18, 2000)
  • K002383 — COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT (September 13, 2000)
  • K983595 — TRANSMYOMETRIAL EMBRYO TRANSFER SET (February 8, 1999)
  • K983596 — INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETT (February 5, 1999)
  • K983642 — COOK MINI-INCUBATOR (February 1, 1999)
  • K983593 — OVUM PICK-UP ASPIRATION NEEDLES (January 21, 1999)

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)
  • 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