FDA 510(k) Application Details - K082102

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K082102
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	APOLLO ENDOSURGERY, INC. 7000 BEE CAVES RD. SUITE 350 AUSTIN, TX 78746 US Other 510(k) Applications for this Company
Contact	DENNIS MCWILLIAMS Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2008
Decision Date	06/14/2010
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review