FDA 510(k) Application Details - K212656

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K212656
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	KARL STORZ Endoscopy America 2151 E. Grand Avenue El Segundo, CA 90245 US Other 510(k) Applications for this Company
Contact	Mario Trujillo Other 510(k) Applications for this Contact
Regulation Number	874.4680   More FDA Info for this Regulation Number
Classification Product Code	EOQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2021
Decision Date	12/29/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review