FDA 510(k) Application Details - K202272

Device Classification Name	Mediastinoscope, Surgical   More FDA Info for this Device
510(K) Number	K202272
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	Winkie Wong 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	08/11/2020
Decision Date	05/11/2021
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