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FDA 510(k)

Endoscope Model EG-580UT and Endoscope Model EG-580UR

K-Number: K221952 · 2022-08-04

ApplicantFujifilm Corporation
Decision Date2022-08-04
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endoscope Model EG-580UT and Endoscope Model EG-580UR is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2022-08-04 under 510(k) number K221952. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoscope Model EG-580UT and Endoscope Model EG-580UR?

Endoscope Model EG-580UT and Endoscope Model EG-580UR is a medical device that received FDA 510(k) clearance on 2022-08-04. The listed applicant is Fujifilm Corporation. The 510(k) number is K221952.

When did Endoscope Model EG-580UT and Endoscope Model EG-580UR receive FDA 510(k) clearance?

Endoscope Model EG-580UT and Endoscope Model EG-580UR received FDA 510(k) clearance on 2022-08-04, under 510(k) number K221952.

Who is the listed applicant for Endoscope Model EG-580UT and Endoscope Model EG-580UR?

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 Endoscope Model EG-580UT and Endoscope Model EG-580UR?

The FDA product code for Endoscope Model EG-580UT and Endoscope Model EG-580UR is ODG.

Other records listing Fujifilm Corporation as applicant

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Related Devices (Code: ODG)

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.

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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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