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FDA 510(k) Application Details - K202968
Device Classification Name
System,Surgical,Computer Controlled Instrument
More FDA Info for this Device
510(K) Number
K202968
Device Name
System,Surgical,Computer Controlled Instrument
Applicant
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 US
Other 510(k) Applications for this Company
Contact
Connor McCarty
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
NAY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/30/2020
Decision Date
12/22/2020
Decision
SESU - SE - WITH LIMITATIONS
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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