FDA 510(k) Application Details - K202925

Device Classification Name	More FDA Info for this Device
510(K) Number	K202925
Device Name	KARL STORZ ICG Imaging System
Applicant	KARL STORZ Endoscopy_America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 US Other 510(k) Applications for this Company
Contact	Alita McElroy Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2020
Decision Date	12/17/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review