K160753 is an FDA 510(k) clearance for the COOK Vacuum Pump. This device is classified as a Accessory, Assisted Reproduction (Class II - Special Controls, product code MQG).
Submitted by William A. Cook Australia Pty. , Ltd. (Eight Mile Plains, AU). The FDA issued a Cleared decision on June 13, 2017, 452 days after receiving the submission on March 18, 2016.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6120.
| 510(k) Number | K160753 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2016 |
| Decision Date | June 13, 2017 |
| Days to Decision | 452 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQG — Accessory, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6120 |