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FDA 510(k)

da Vinci Handheld Camera

K-Number: K241913 · 2024-08-28

Decision Date2024-08-28
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

da Vinci Handheld Camera is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical Operations, Inc.. It received FDA 510(k) clearance on 2024-08-28 under 510(k) 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. The listed applicant is Intuitive Surgical Operations, Inc.. The 510(k) number is K241913.

When did da Vinci Handheld Camera receive FDA 510(k) clearance?

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

Who is the listed applicant for da Vinci Handheld Camera?

The FDA 510(k) record lists Intuitive Surgical Operations, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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