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510(k) K173431

Towako Transmyometrial Embryo Transfer Set by William A. Cook Australia Pty. , Ltd. — Product Code MQF

K173431 is an FDA 510(k) premarket notification submitted by William A. Cook Australia Pty. , Ltd. for the device "Towako Transmyometrial Embryo Transfer Set". The FDA issued a decision of Substantially Equivalent on May 18, 2018. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. William A. Cook Australia Pty. , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2018
Date Received
November 2, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6110
Review Panel
OB
Submission Type

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

  • 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)
  • K152904 — SYDNEY IVF EMBRYO BIOPSY MEDIUM (December 3, 2015)

Other clearances for product code MQF

  • K253354 — Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175 (February 12, 2026)
  • K243373 — Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - (July 23, 2025)
  • K240307 — VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) (August 16, 2024)
  • K231730 — FemaSeed Intratubal Insemination (September 22, 2023)
  • K220010 — Daylily Single Use Sterile Embryo Transfer Catheter (December 16, 2022)
  • K200248 — Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators (July 1, 2020)
  • K192540 — Kitazato ET Catheters (May 1, 2020)
  • K190522 — Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intr (November 14, 2019)
  • K191015 — Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Cat (May 17, 2019)
  • K180302 — Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, S (October 24, 2018)

FDA data resources