K243373
- 510(k) number
- K243373
- Device name
- 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)
- Applicant
- Vitrolife Sweden AB SE
- Product code
- MQF — Catheter, Assisted Reproduction
- Decision date
- 2025-07-23
- Date received
- 2024-10-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243373.pdf
Official FDA record: K243373
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.