Home / 510(k) Clearances / K143724

510(k) K143724

COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit by William A. Cook Australia Pty. , Ltd. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2015
Date Received
December 29, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type

Other clearances by William A. Cook Australia Pty. , Ltd.

  • K173431 — Towako Transmyometrial Embryo Transfer Set (May 18, 2018)
  • K171611 — Double Lumen Ovum Aspiration Needles (December 15, 2017)
  • K160753 — COOK Vacuum Pump (June 13, 2017)
  • K170257 — Sydney IVF Culture Oil (February 24, 2017)
  • K153478 — Sydney IVF Gamete Buffer (August 15, 2016)
  • K152717 — Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit (May 6, 2016)
  • K160814 — Sydney IVF Sperm Cryopreservation Buffer (April 22, 2016)
  • K151367 — Sydney IVF Hyaluronidase (January 27, 2016)
  • K153290 — Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cl (January 27, 2016)
  • K152782 — SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT (December 21, 2015)

Other clearances for product code MQL

  • K252672 — CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) (February 20, 2026)
  • K250445 — Fast Warm - NX (September 12, 2025)
  • K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin (August 27, 2025)
  • K251305 — Ultra-Fast Vitri; Ultra-Fast Warm (August 26, 2025)
  • K242640 — FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentami (May 30, 2025)
  • K242089 — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) (April 10, 2025)
  • K242561 — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (April 10, 2025)
  • K242107 — CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); (March 21, 2025)
  • K241833 — V-GRAD (March 21, 2025)
  • K242043 — Sperm Freezing Medium (January 8, 2025)