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FDA 510(k)

Video Laparoscope, Video Processor, Light Source

K-Number: K192918 · 2020-02-20

Decision Date2020-02-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Video Laparoscope, Video Processor, Light Source is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2020-02-20 under approval number K192918. 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 Video Laparoscope, Video Processor, Light Source?

Video Laparoscope, Video Processor, Light Source is a medical device that received FDA 510(k) clearance on 2020-02-20. It is manufactured by Fujifilm Corporation. The 510(k) number is K192918.

When was Video Laparoscope, Video Processor, Light Source approved by the FDA?

Video Laparoscope, Video Processor, Light Source received FDA 510(k) clearance on 2020-02-20, under approval number K192918.

What company makes Video Laparoscope, Video Processor, Light Source?

Video Laparoscope, Video Processor, Light Source is manufactured by Fujifilm Corporation.

What is the FDA product code for Video Laparoscope, Video Processor, Light Source?

The FDA product code for Video Laparoscope, Video Processor, Light Source 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.