FDA 510(k) Application Details - K221098

Device Classification Name	More FDA Info for this Device
510(K) Number	K221098
Device Name	Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
Applicant	Stryker Corporation Boetzinger Strasse 41 Freiburg D-79111 DE Other 510(k) Applications for this Company
Contact	Maya Schiel Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2022
Decision Date	07/12/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review