FDA 510(k) Application Details - K213271

Device Classification Name	Endoscopic Tissue Approximation Device   More FDA Info for this Device
510(K) Number	K213271
Device Name	Endoscopic Tissue Approximation Device
Applicant	Health Value Creation BV, trading as Corporis Medical Oxfordlaan 55 Maastricht 6229 EV NL Other 510(k) Applications for this Company
Contact	Kim Sondeijker Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2021
Decision Date	08/31/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review