FDA 510(k) Application Details - K182188

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K182188
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 US Other 510(k) Applications for this Company
Contact	Sarah Rizk 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	08/13/2018
Decision Date	02/14/2019
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