K222969 is an FDA 510(k) clearance for the FERTI-LILY Conception Cup, a Cap, Cervical (Class II — Special Controls, product code HDR), submitted by Rosesta Medical BV (Amsterdam, NL). The FDA issued a Cleared decision on June 23, 2023, 269 days after receiving the submission on September 27, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.
| 510(k) Number | K222969 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 27, 2022 |
| Decision Date | June 23, 2023 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HDR — Cap, Cervical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5250 |