510(k) Report

FDA applicant

Willian A. Cook Australia Pty, Ltd.

Eight Mile Plains, AU2 decisions2016–20180 recalls

FDA records 2 decisions for Willian A. Cook Australia Pty, Ltd. (Eight Mile Plains, AU) from 2016 to 2018: 2 510(k) clearances. Most are in product codes MQL (Media, Reproductive) and MQE (Needle, Assisted Reproduction). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Willian A. Cook Australia Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2016: 12018: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Willian A. Cook Australia Pty, Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Willian A. Cook Australia Pty, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MQLMedia, Reproductive1decision
  • MQENeedle, Assisted Reproduction1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K171625Single Lumen Ovum Aspiration NeedlesWillian A. Cook Australia Pty, Ltd. · 2018
  • K152682Sydney IVF Cryopreservation Kit, Sydney IVF Thawing KitWillian A. Cook Australia Pty, Ltd. · 2016

All 2 as Willian A. Cook Australia Pty, Ltd. →