FDA 510(k) Application Details - K193118

Device Classification Name	More FDA Info for this Device
510(K) Number	K193118
Device Name	TGS Guidewire and updated Scopis Software
Applicant	Stryker ENT 3600 Holly Lane North, Suite 40 Plymouth, MN 55447 US Other 510(k) Applications for this Company
Contact	Bruce Backlund 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	11/12/2019
Decision Date	02/21/2020
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