FDA 510(k) Application Details - K242211

Device Classification Name	Tube, Gastro-Enterostomy   More FDA Info for this Device
510(K) Number	K242211
Device Name	Tube, Gastro-Enterostomy
Applicant	CoapTech Inc. 101 W. Dickman St. Suite 700 Baltimore, MD 21230 US Other 510(k) Applications for this Company
Contact	Jack Kent Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2024
Decision Date	04/29/2025
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