FDA 510(k) Application Details - K243412

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K243412
Device Name	Catheter, Biliary, Diagnostic
Applicant	Q3 Medical USA, LLC (c/o Q3 Medical Devices Ltd.) 1800 Camden Rd, Suite 107 Charlotte, NC 28203 US Other 510(k) Applications for this Company
Contact	Eric Mangiardi Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	FGE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2024
Decision Date	07/16/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review