FDA 510(k) Application Details - K243820

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K243820
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	Dornier MedTech America 1155 Roberts Blvd Suite 100 Kennesaw, GA 30144 US Other 510(k) Applications for this Company
Contact	John Hoffer 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	12/12/2024
Decision Date	01/31/2025
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