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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 the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2020-02-20 under 510(k) 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. The listed applicant is Fujifilm Corporation. The 510(k) number is K192918.

When did Video Laparoscope, Video Processor, Light Source receive FDA 510(k) clearance?

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

Who is the listed applicant for Video Laparoscope, Video Processor, Light Source?

The FDA 510(k) record lists Fujifilm Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Fujifilm Corporation as applicant

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.

View all 67 devices →

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