FDA 510(k) Application Details - DEN210045

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210045
Device Name	APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
Applicant	Apollo Endosurgery, Inc. 1120 S. Capital of Texas Hwy., Bldg 1, Ste 300 Austin, TX 78746 US Other 510(k) Applications for this Company
Contact	David M. Hooper 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	09/30/2021
Decision Date	07/12/2022
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review