FDA 510(k) Application Details - DEN220006

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220006
Device Name	ProdiGI
Applicant	Covidien LLC 3062 Bunker Hill Lane Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Liron Bar Yaakov Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/14/2022
Decision Date	06/13/2022
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