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)— 510(k) K243373

Substantially Equivalent

Vitrolife Sweden AB

FDA 510(k) clearance K243373 for 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), Substantially Equivalent on 2025-07-23. Applicant: Vitrolife Sweden AB.

Clearance details

Applicant: Vitrolife Sweden AB
Product code: Code MQF
Advisory panel: Obstetrics/Gynecology
Date received: 2024-10-30
Decision date: 2025-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Västra Frölunda, SE

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