FDA 510(k) Application Details - K213606

Device Classification Name	Gastroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K213606
Device Name	Gastroscope And Accessories, Flexible/Rigid
Applicant	EvoEndo Inc 12649 East Caley Ave, Suite 116 Centennial, CO 80111 US Other 510(k) Applications for this Company
Contact	Heather Underwood Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2021
Decision Date	02/14/2022
Decision	SESE - SUBST EQUIV
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