FDA 510(k) Application Details - DEN200016

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200016
Device Name	EndoRotor Device
Applicant	Interscope, Inc 100 Main Street, Suite 108 Whitinsville, MA 01588 US Other 510(k) Applications for this Company
Contact	Jeffery Ryan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2020
Decision Date	12/23/2020
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