FDA 510(k) Application Details - K232250

Device Classification Name	More FDA Info for this Device
510(K) Number	K232250
Device Name	SurgiCount+ System
Applicant	Stryker Instruments 1941 Stryker Way Portage, MI 49002 US Other 510(k) Applications for this Company
Contact	Patti Arndt Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2023
Decision Date	01/11/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review