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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
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