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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 K240135
Device Name Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)
Applicant
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale,  CA  94086
Applicant Contact Jennifer Siu
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale,  CA  94086
Correspondent Contact Jennifer Siu
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received01/18/2024
Decision Date 04/03/2024
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
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