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FDA 510(k)

da Vinci Handheld Camera

K-Number: K241913 · 2024-08-28

ApplicantIntuitive Surgical Operations, Inc.
Decision Date2024-08-28
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

da Vinci Handheld Camera is a medical device manufactured by Intuitive Surgical Operations, Inc.. It received FDA 510(k) clearance on 2024-08-28 under approval number K241913. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the da Vinci Handheld Camera?

da Vinci Handheld Camera is a medical device that received FDA 510(k) clearance on 2024-08-28. It is manufactured by Intuitive Surgical Operations, Inc.. The 510(k) number is K241913.

When was da Vinci Handheld Camera approved by the FDA?

da Vinci Handheld Camera received FDA 510(k) clearance on 2024-08-28, under approval number K241913.

What company makes da Vinci Handheld Camera?

da Vinci Handheld Camera is manufactured by Intuitive Surgical Operations, Inc..

What is the FDA product code for da Vinci Handheld Camera?

The FDA product code for da Vinci Handheld Camera is GCJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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