da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K-Number: K211784 · 2021-08-06
ApplicantIntuitive Surgical, Inc.
Decision Date2021-08-06
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2021-08-06 under approval number K211784. The device is classified under product code NAY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)?
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) is a medical device that received FDA 510(k) clearance on 2021-08-06. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K211784.
When was da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) approved by the FDA?
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) received FDA 510(k) clearance on 2021-08-06, under approval number K211784.
What company makes da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)?
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) is manufactured by Intuitive Surgical, Inc..
What is the FDA product code for da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)?
The FDA product code for da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) is NAY.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.