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FDA 510(k)

FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5

K-Number: K183683 · 2019-02-27

ApplicantFujifilm Corporation
Decision Date2019-02-27
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2019-02-27 under approval number K183683. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5?

FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 is a medical device that received FDA 510(k) clearance on 2019-02-27. It is manufactured by Fujifilm Corporation. The 510(k) number is K183683.

When was FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 approved by the FDA?

FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 received FDA 510(k) clearance on 2019-02-27, under approval number K183683.

What company makes FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5?

FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 is manufactured by Fujifilm Corporation.

What is the FDA product code for FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5?

The FDA product code for FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 is FDA.

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Related Devices (Code: FDA)

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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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