William A. Cook Australia Pty. , Ltd.: FDA clearances and approvals
William A. Cook Australia Pty. , Ltd. has 14 FDA 510(k) clearances (first 2009, latest 2018), across 4 product codes in 1 review panel. Median 510(k) review time: 197 days. Since 2017 its median was 197 days, against 210 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 76 |
| 2015 | 3 | 87 |
| 2016 | 5 | 228 |
| 2017 | 3 | 197 |
| 2018 | 1 | 197 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, William A. Cook Australia Pty. , Ltd.'s cleared 510(k)s took a median 197 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 210 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQL | Media, Reproductive | 10 | 10 |
| MQE | Needle, Assisted Reproduction | 2 | 2 |
| MQF | Catheter, Assisted Reproduction | 1 | 1 |
| MQG | Accessory, Assisted Reproduction | 1 | 1 |
Review panels
Most recent William A. Cook Australia Pty. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173431 | Towako Transmyometrial Embryo Transfer Set | MQF | 2018-05-18 | 197 |
| K171611 | Double Lumen Ovum Aspiration Needles | MQE | 2017-12-15 | 197 |
| K160753 | COOK Vacuum Pump | MQG | 2017-06-13 | 452 |
| K170257 | Sydney IVF Culture Oil | MQL | 2017-02-24 | 28 |
| K153478 | Sydney IVF Gamete Buffer | MQL | 2016-08-15 | 257 |
| K152717 | Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit | MQL | 2016-05-06 | 228 |
| K160814 | Sydney IVF Sperm Cryopreservation Buffer | MQL | 2016-04-22 | 29 |
| K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium | MQL | 2016-01-27 | 75 |
| K151367 | Sydney IVF Hyaluronidase | MQL | 2016-01-27 | 251 |
| K152782 | SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT | MQL | 2015-12-21 | 87 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named William A. Cook Australia Pty. , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does William A. Cook Australia Pty. , Ltd. have?
William A. Cook Australia Pty. , Ltd. has 14 FDA 510(k) clearances (first 2009, latest 2018), across 4 product codes in 1 review panel.
How long does FDA take to clear William A. Cook Australia Pty. , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across William A. Cook Australia Pty. , Ltd.'s cleared 510(k)s is 197 days. Since 2017: 197 days, versus 210 days for all cleared 510(k)s in the same product codes.
What devices does William A. Cook Australia Pty. , Ltd. make?
Its most frequent FDA product codes are MQL (Media, Reproductive, 10); MQE (Needle, Assisted Reproduction, 2); MQF (Catheter, Assisted Reproduction, 1).
Has William A. Cook Australia Pty. , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching William A. Cook Australia Pty. , Ltd. Related entities may recall under other names.
Next steps
- See all 14 William A. Cook Australia Pty. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MQL, William A. Cook Australia Pty. , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.