William A. Cook Australia Pty, Ltd.
EIGHT MILE PLAINS Queensland, AU
WILLIAM A. COOK AUSTRALIA PTY, LTD. appears in FDA device records in EIGHT MILE PLAINS Queensland, AU. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for William A. Cook Australia Pty, Ltd. between 2009 and 2018. The busiest year on record is 2016, with 5. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 5 |
| 2017 | 3 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K173431 | Towako Transmyometrial Embryo Transfer Set | MQF | Substantially Equivalent | |
| K171611 | Double Lumen Ovum Aspiration Needles | MQE | Substantially Equivalent | |
| K160753 | COOK Vacuum Pump | MQG | Substantially Equivalent | |
| K170257 | Sydney IVF Culture Oil | MQL | Substantially Equivalent | |
| K153478 | Sydney IVF Gamete Buffer | MQL | Substantially Equivalent | |
| K152717 | Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit | MQL | Substantially Equivalent | |
| K160814 | Sydney IVF Sperm Cryopreservation Buffer | MQL | Substantially Equivalent | |
| K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium | MQL | Substantially Equivalent | |
| K151367 | Sydney IVF Hyaluronidase | MQL | Substantially Equivalent | |
| K152782 | SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT | MQL | Substantially Equivalent | |
| K152904 | SYDNEY IVF EMBRYO BIOPSY MEDIUM | MQL | Substantially Equivalent | |
| K143724 | COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit | MQL | Substantially Equivalent | |
| K141365 | OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN | MQE | Substantially Equivalent | |
| K082363 | COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS | MQL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9680654 | 3007530363 | WILLIAM A. COOK AUSTRALIA PTY, LTD. | 95 BRANDL ST, EIGHT MILE PLAINS Queensland 4113 AU | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain