FDA 510(k) Application Details - K191529

Device Classification Name System,Surgical,Computer Controlled Instrument

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510(K) Number K191529
Device Name System,Surgical,Computer Controlled Instrument
Applicant Intuitive Surgical
1266 Kifer Road
Sunnyvale, CA 94086 US
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Contact Brandon Hansen
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Regulation Number 876.1500

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Classification Product Code NAY
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Date Received 06/10/2019
Decision Date 02/06/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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