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FDA 510(k)

FUJIFILM Ultrasonic Endoscope

K-Number: K183433 · 2019-09-05

ApplicantFujifilm Corporation
Decision Date2019-09-05
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Ultrasonic Endoscope is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2019-09-05 under approval number K183433. 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?

FUJIFILM Ultrasonic Endoscope is a medical device that received FDA 510(k) clearance on 2019-09-05. It is manufactured by Fujifilm Corporation. The 510(k) number is K183433.

When was FUJIFILM Ultrasonic Endoscope approved by the FDA?

FUJIFILM Ultrasonic Endoscope received FDA 510(k) clearance on 2019-09-05, under approval number K183433.

What company makes FUJIFILM Ultrasonic Endoscope?

FUJIFILM Ultrasonic Endoscope is manufactured by Fujifilm Corporation.

What is the FDA product code for FUJIFILM Ultrasonic Endoscope?

The FDA product code for FUJIFILM Ultrasonic Endoscope is ODG.

Other Devices by Fujifilm Corporation

K182051FUJIFILM Duodenoscope Model K181773Synapse 3D Optional Tools K180341FUJIFILM 600 Series Endoscope EG-600WR v2 K181763FUJIFILM Ultrasonic Endoscope K180711FUJIFILM Endoscopic CO2 Regulator GW-100 K180405FUJIFILM Endoscope Models EC-600HL and EC-600LS

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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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