FDA 510(k) Application Details - K230752

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K230752
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	Fujifilm Healthcare Americas Corporation 81 Hartwell Avenue Suite 300 Lexington, MA 02421 US Other 510(k) Applications for this Company
Contact	Kotei Aoki 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	03/17/2023
Decision Date	09/15/2023
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