FDA 510(k) Application Details - K240544

Device Classification Name	More FDA Info for this Device
510(K) Number	K240544
Device Name	Epitomee
Applicant	Epitomee Medical Ltd. 17 Hatochen St. Caesarea 3079892 IL Other 510(k) Applications for this Company
Contact	Ruthie Amir Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2024
Decision Date	09/13/2024
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