K243373 is an FDA 510(k) clearance for the Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500). This device is classified as a Catheter, Assisted Reproduction (Class II - Special Controls, product code MQF).
Submitted by Vitrolife Sweden AB (Västra Frölunda, SE). The FDA issued a Cleared decision on July 23, 2025, 266 days after receiving the submission on October 30, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6110.
| 510(k) Number | K243373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2024 |
| Decision Date | July 23, 2025 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQF — Catheter, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6110 |