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FDA 510(k) Application Details - K214095
Device Classification Name
System,Surgical,Computer Controlled Instrument
More FDA Info for this Device
510(K) Number
K214095
Device Name
System,Surgical,Computer Controlled Instrument
Applicant
Intuitive Surgical, Inc.
1266 Kifer Road, Building 101
Sunnyvale, CA 94086 US
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Contact
Kunal Gunjal
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
NAY
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More FDA Info for this Product Code
Date Received
12/28/2021
Decision Date
08/15/2022
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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