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FDA 510(k)

da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments

K-Number: K214095 · 2022-08-15

ApplicantIntuitive Surgical, Inc.
Decision Date2022-08-15
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2022-08-15 under approval number K214095. 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/Xi (IS4200/IS4000) 8mm Reusable Instruments?

da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments is a medical device that received FDA 510(k) clearance on 2022-08-15. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K214095.

When was da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments approved by the FDA?

da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments received FDA 510(k) clearance on 2022-08-15, under approval number K214095.

What company makes da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments?

da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments is manufactured by Intuitive Surgical, Inc..

What is the FDA product code for da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments?

The FDA product code for da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments is NAY.

Other Devices by Intuitive Surgical, Inc.

K162411da Vinci Xi 12 – 8 mm Reducer K153276da Vinci Xi Surgical System K161271da Vinci Xi Surgical System K152578da Vinci Surgical System, Model IS4000 K152448da Vinci Single-Site Instrument and Accessories K152421IS4000 Stapler 30 Instrument and Stapler 30 Reloads

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Related Devices (Code: NAY)

K162411da Vinci Xi 12 – 8 mm ReducerIntuitive Surgical, Inc. K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc. K161271da Vinci Xi Surgical SystemIntuitive Surgical, Inc. K152892da Vinci Xi Surgical SystemIntuitive Surgical K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc. K152448da Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc.

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.

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