Cleared Traditional

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)

K243373 · Vitrolife Sweden AB · Obstetrics & Gynecology

Jul 2025

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K243373 is an FDA 510(k) clearance for the 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), a Catheter, Assisted Reproduction (Class II — Special Controls, product code MQF), submitted by Vitrolife Sweden AB (V?stra Fr?lunda, 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 review panel. Regulated under 21 CFR 884.6110.

Submission Details

510(k) Number	K243373 FDA.gov
FDA Decision	Cleared 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