da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
K-Number: K223080 · 2022-11-22
ApplicantIntuitive Surgical, Inc.
Decision Date2022-11-22
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2022-11-22 under approval number K223080. 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 X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)?
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) is a medical device that received FDA 510(k) clearance on 2022-11-22. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K223080.
When was da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) approved by the FDA?
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) received FDA 510(k) clearance on 2022-11-22, under approval number K223080.
What company makes da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)?
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) is manufactured by Intuitive Surgical, Inc..
What is the FDA product code for da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)?
The FDA product code for da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) is NAY.
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Other Devices by Intuitive Surgical, Inc.
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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.