FDA 510(k) Application Details - K243373

Device Classification Name	Catheter, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K243373
Device Name	Catheter, Assisted Reproduction
Applicant	Vitrolife Sweden AB Gustaf Werners gata 2 Gothenburg SE Other 510(k) Applications for this Company
Contact	Ann-Cathrine Ericson Other 510(k) Applications for this Contact
Regulation Number	884.6110   More FDA Info for this Regulation Number
Classification Product Code	MQF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2024
Decision Date	07/23/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review