FDA 510(k) Application Details - K251542

Device Classification Name	Endoscopic Ultrasound System, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K251542
Device Name	Endoscopic Ultrasound System, Gastroenterology-Urology
Applicant	OnePass Medical Ltd. 1st The Four Street Katzrin Industrial Park Katzrin 1290000 IL Other 510(k) Applications for this Company
Contact	Jacob Ben Arie Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2025
Decision Date	07/18/2025
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