FDA 510(k) Application Details - K211301

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K211301
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	Neptune Medical, Inc. 1828 El Camino Real Burlingame, CA 94010 US Other 510(k) Applications for this Company
Contact	Alex Tilson 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	04/29/2021
Decision Date	05/28/2021
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