da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
K-Number: K240852 · 2025-06-11
ApplicantIntuitive Surgical, Inc.
Decision Date2025-06-11
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 2025-06-11 under approval number K240852. 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 2025-06-11. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K240852.
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 2025-06-11, under approval number K240852.
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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Related PubMed Literature
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Other Devices by Intuitive Surgical, Inc.
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.