FDA 510(k) Application Details - K231553

Device Classification Name	Endoscopic Tissue Approximation Device   More FDA Info for this Device
510(K) Number	K231553
Device Name	Endoscopic Tissue Approximation Device
Applicant	Apollo Endosurgery Inc. 1120 South Capital of Texas Hwy., Suite 300 Austin, TX 78746 US Other 510(k) Applications for this Company
Contact	James Shene 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	05/30/2023
Decision Date	06/29/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review