FDA 510(k) Application Details - K241424

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K241424
Device Name	Catheter, Retention Type, Balloon
Applicant	InnoCare Urologics, LLC 7175 SW 47th Street, Suite 207 Miami, FL 33155 US Other 510(k) Applications for this Company
Contact	Patrick McCain Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2024
Decision Date	09/18/2024
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