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FDA 510(k)

da Vinci Handheld Camera

K-Number: K191043 · 2019-06-06

ApplicantIntuitive Surgical, Inc.
Decision Date2019-06-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

da Vinci Handheld Camera is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2019-06-06 under approval number K191043. 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 2019-06-06. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K191043.

When was da Vinci Handheld Camera approved by the FDA?

da Vinci Handheld Camera received FDA 510(k) clearance on 2019-06-06, under approval number K191043.

What company makes da Vinci Handheld Camera?

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

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

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

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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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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