FDA 510(k) Application Details - K222006

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K222006
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	G-Flex Europe SPRL 20, Rue de lÆindustrie Nivelles 1400 BE Other 510(k) Applications for this Company
Contact	Thierry Cremer 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	07/07/2022
Decision Date	04/03/2023
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