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FDA 510(k)

FUJIFILM Ultrasonic Endoscope EG-740UT

K-Number: K221238 · 2022-08-19

Decision Date2022-08-19
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Ultrasonic Endoscope EG-740UT is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K221238. 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 FUJIFILM Ultrasonic Endoscope EG-740UT?

FUJIFILM Ultrasonic Endoscope EG-740UT is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Fujifilm Corporation. The 510(k) number is K221238.

When did FUJIFILM Ultrasonic Endoscope EG-740UT receive FDA 510(k) clearance?

FUJIFILM Ultrasonic Endoscope EG-740UT received FDA 510(k) clearance on 2022-08-19, under 510(k) number K221238.

Who is the listed applicant for FUJIFILM Ultrasonic Endoscope EG-740UT?

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 FUJIFILM Ultrasonic Endoscope EG-740UT?

The FDA product code for FUJIFILM Ultrasonic Endoscope EG-740UT is ODG.

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.

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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.

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.