FDA 510(k) Application Details - K251116

Device Classification Name	Catheter, Straight   More FDA Info for this Device
510(K) Number	K251116
Device Name	Catheter, Straight
Applicant	Coloplast Corp. 1601 West River Road North Minneapolis, MN 55411 US Other 510(k) Applications for this Company
Contact	Troy Thome Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2025
Decision Date	06/27/2025
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