FDA 510(k) Application Details - K213194

Device Classification Name	Mediastinoscope, Surgical   More FDA Info for this Device
510(K) Number	K213194
Device Name	Mediastinoscope, Surgical
Applicant	Karl Storz Endoscopy America, Inc. 2151 E. Grand Ave El Segundo, CA 90245 US Other 510(k) Applications for this Company
Contact	Alita McElroy Other 510(k) Applications for this Contact
Regulation Number	874.4720   More FDA Info for this Regulation Number
Classification Product Code	EWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2021
Decision Date	06/23/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review