FDA 510(k) Application Details - K231854

Device Classification Name	More FDA Info for this Device
510(K) Number	K231854
Device Name	1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
Applicant	Stryker 5900 Optical Court San Jose, CA 95138 US Other 510(k) Applications for this Company
Contact	April Malmborg 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	06/23/2023
Decision Date	09/20/2023
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