da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
K-Number: K240723 · 2024-05-24
ApplicantIntuitive Surgical
Decision Date2024-05-24
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. It received FDA 510(k) clearance on 2024-05-24 under approval number K240723. 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 2024-05-24. It is manufactured by Intuitive Surgical. The 510(k) number is K240723.
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 2024-05-24, under approval number K240723.
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.
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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Other Devices by Intuitive Surgical
Related Devices (Code: 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.