FDA 510(k) Application Details - K241523

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K241523
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	Laborie Medical Technologies Corp. 180 International Drive Portsmouth, NH 03801 US Other 510(k) Applications for this Company
Contact	Thomas Hirte 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	05/29/2024
Decision Date	08/27/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review