Data / Medical devices / Australia / William A. Cook Australia Pty, Ltd.
William A. Cook Australia Pty, Ltd.: FDA-registered device maker in EIGHT MILE PLAINS Queensland, Australia, 7 510(k) clearances and 1 PMA approval
William A. Cook Australia Pty, Ltd. is registered with the FDA (registration 9680654) in EIGHT MILE PLAINS Queensland, Australia. It lists 4 device types. The FDA files 7 510(k) clearances and 1 PMA approval under its listings, the newest dated January 12, 2018. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9680654
- FEI number
- 3007530363
- Address
- 95 Brandl ST, EIGHT MILE PLAINS Queensland, Australia, 4113
- Owner or operator
- William A Cook Australia Pty Ltd (9010455)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 27, 2007
- Registered through
- 2027
- Brand names listed
- COOK Vacuum Pump, Cook Mini-Incubator, Cook Test Tube Heater, Cook Ultra Quiet Vacuum Pump/Access, Double Lumen Ovum Aspiration Needles, MINC+ Benchtop Incubator, Ovum Pick-Up Aspiration Needles, Single Lumen Ovum Aspiration Needles and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Assisted Reproduction | MQG | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Accessory, Assisted Reproduction, Exempt | PUB | 2 | Specification developer | accessdata.fda.gov |
| Needle, Assisted Reproduction | MQE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 12, 2018 | K171625 | Single Lumen Ovum Aspiration Needles | MQE | Substantially Equivalent | Willian A. Cook Australia Pty, Ltd. | accessdata.fda.gov |
| December 15, 2017 | K171611 | Double Lumen Ovum Aspiration Needles | MQE | Substantially Equivalent | William A. Cook Australia Pty. , Ltd. | accessdata.fda.gov |
| June 13, 2017 | K160753 | COOK Vacuum Pump | MQG | Substantially Equivalent | William A. Cook Australia Pty. , Ltd. | accessdata.fda.gov |
| October 27, 1999 | K992070 | COOK ULTRA QUIET VACUUM PUMP & REGULATOR | MQG | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| February 1, 1999 | K983642 | COOK MINI-INCUBATOR | MQG | Substantially Equivalent | Cook Ob/Gyn | accessdata.fda.gov |
| January 21, 1999 | K983593 | OVUM PICK-UP ASPIRATION NEEDLES | MQE | Substantially Equivalent | Cook Ob/Gyn | accessdata.fda.gov |
| December 16, 1998 | K983609 | COOK TEST TUBE HEATER | MQG | Substantially Equivalent | Cook Ob/Gyn | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 23, 2003 | P020018 | ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM | MIH | 65 | September 17, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory, Assisted Reproduction
- All makers of Needle, Assisted Reproduction
- All makers of System, Endovascular Graft, Aortic Aneurysm Treatment
- All makers of Accessory, Assisted Reproduction, Exempt
Updated September 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.