FDA 510(k) Application Details - K241595

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K241595
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	Veol Medical Technologies Pvt Ltd. A 747, MIDC Pawane, TTC Industrial Area, Kopar Khairane, Navi Mumbai 400705 IN Other 510(k) Applications for this Company
Contact	Sneha Pandit Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2024
Decision Date	02/27/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review