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FDA 510(k)

da Vinci Xi EndoWrist Instruments and Accessories

K-Number: K170645 · 2017-09-11

Decision Date2017-09-11
Product CodeNAY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

da Vinci Xi EndoWrist Instruments and Accessories is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2017-09-11 under approval number K170645. 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 EndoWrist Instruments and Accessories?

da Vinci Xi EndoWrist Instruments and Accessories is a medical device that received FDA 510(k) clearance on 2017-09-11. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K170645.

When was da Vinci Xi EndoWrist Instruments and Accessories approved by the FDA?

da Vinci Xi EndoWrist Instruments and Accessories received FDA 510(k) clearance on 2017-09-11, under approval number K170645.

What company makes da Vinci Xi EndoWrist Instruments and Accessories?

da Vinci Xi EndoWrist Instruments and Accessories is manufactured by Intuitive Surgical, Inc..

What is the FDA product code for da Vinci Xi EndoWrist Instruments and Accessories?

The FDA product code for da Vinci Xi EndoWrist Instruments and Accessories is NAY.

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Official Source

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