Clearance Summary
Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) received FDA 510(k) clearance under submission number K243373, sponsored by Vitrolife Sweden AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2025-07-23.
- Submission: K243373
- Applicant / Sponsor: Vitrolife Sweden AB
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6110
- Decision date: 2025-07-23
Classification & Regulation
This clearance is catalogued under FDA product code MQF and 21 CFR 884.6110, within the Obstetrics/Gynecology review panel as a Class II device.