Home / 510(k) Clearances / K160753

510(k) K160753

COOK Vacuum Pump by William A. Cook Australia Pty. , Ltd. — Product Code MQG

K160753 is an FDA 510(k) premarket notification submitted by William A. Cook Australia Pty. , Ltd. for the device "COOK Vacuum Pump". The FDA issued a decision of Substantially Equivalent on June 13, 2017. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120. William A. Cook Australia Pty. , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2017
Date Received
March 18, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6120
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)
  • 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 MQG

  • K260194 — Vacuum Pump (Model: AD-VPUM-500) (April 28, 2026)
  • K242684 — Harioculture TL-16 Time-lapse Incubator (May 22, 2025)
  • K232493 — Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) (May 7, 2024)
  • K180188 — Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish (June 7, 2018)
  • K173264 — EmbryoScope+ (May 11, 2018)
  • K180304 — Geri Embryo Incubator and Geri Dish (April 20, 2018)
  • K171736 — Geri Embryo Incubator and Geri Dish (November 15, 2017)
  • K160504 — RI Witness Embryology Heated Plate (July 18, 2016)
  • K151357 — MIRI TL (April 22, 2016)
  • K133712 — EMBRYOVIEWER SOFTWARE (August 8, 2014)

FDA data resources