FDA 510(k) Application Details - K221293

Device Classification Name	Anti Fog Solution And Accessories, Endoscopy   More FDA Info for this Device
510(K) Number	K221293
Device Name	Anti Fog Solution And Accessories, Endoscopy
Applicant	JDI Surgical, Inc. 9925 Silver Maple Way Highlands Ranch, CO 80129 US Other 510(k) Applications for this Company
Contact	Dwight Lenox Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2022
Decision Date	07/07/2022
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