FDA 510(k) Application Details - K232544

Device Classification Name	More FDA Info for this Device
510(K) Number	K232544
Device Name	Apollo ESG NXT System, Apollo REVISE NXT System
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	More FDA Info for this Regulation Number
Classification Product Code	QTD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/22/2023
Decision Date	09/18/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review