K242640 is an FDA 510(k) clearance for the FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Fertipro NV (Beernem, BE). The FDA issued a Cleared decision on May 30, 2025, 269 days after receiving the submission on September 3, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K242640 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 03, 2024 |
| Decision Date | May 30, 2025 |
| Days to Decision | 269 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 |