FDA 510(k) Application Details - K242173

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K242173
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	Coloplast Corp. 1601 West River Road North Minneapolis, MN 55411 US Other 510(k) Applications for this Company
Contact	Jennifer Tvrdik Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2024
Decision Date	11/12/2024
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