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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bronchoscope (flexible or rigid)
510(k) Number K182188
Device Name Ion Endoluminal System ; Flexision Biopsy Needle
Intuitive Surgical
1266 Kifer Road
Sunnyvale,  CA  94086
Applicant Contact Sarah Rizk
Intuitive Surgical
1266 Kifer Road
Sunnyvale,  CA  94086
Correspondent Contact Sarah Rizk
Regulation Number874.4680
Classification Product Code
Date Received08/13/2018
Decision Date 02/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls