FDA 510(k) Application Details - K250910

Device Classification Name	Dilator, Catheter, Ureteral   More FDA Info for this Device
510(K) Number	K250910
Device Name	Dilator, Catheter, Ureteral
Applicant	Urotronic, Inc. 2495 Xenium Lane N Minneapolis, MN 55441 US Other 510(k) Applications for this Company
Contact	Alex Zuniga Other 510(k) Applications for this Contact
Regulation Number	876.5470   More FDA Info for this Regulation Number
Classification Product Code	EZN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2025
Decision Date	05/22/2025
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