K202862 is an FDA 510(k) clearance for the Gx-IVF, Gx-TL, Gx-MOPS PLUS. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Vitrolife Sweden AB (Västra Frölunda, SE). The FDA issued a Cleared decision on May 14, 2021, 228 days after receiving the submission on September 28, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K202862 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2020 |
| Decision Date | May 14, 2021 |
| Days to Decision | 228 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQL — Media, Reproductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6180 |