FDA 510(k) Application Details - K201744

Device Classification Name	Endoscopic Tissue Approximation Device   More FDA Info for this Device
510(K) Number	K201744
Device Name	Endoscopic Tissue Approximation Device
Applicant	Anchora Medical, Ltd. Beit Tavor, Entrance 2, 3rd floor I.Z. Yokneam 2069202 IL Other 510(k) Applications for this Company
Contact	Yoni Epstein 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	06/25/2020
Decision Date	06/17/2021
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