K161970 is an FDA 510(k) clearance for the Follicle Aspiration Set. This device is classified as a Needle, Assisted Reproduction (Class II - Special Controls, product code MQE).
Submitted by Vitrolife Sweden AB (Västra Frölunda, SE). The FDA issued a Cleared decision on June 14, 2017, 331 days after receiving the submission on July 18, 2016.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6100.
| 510(k) Number | K161970 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2016 |
| Decision Date | June 14, 2017 |
| Days to Decision | 331 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQE — Needle, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6100 |