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FDA 510(k)

GC Fuji Direct

K-Number: K172382 · 2018-04-02

ApplicantGC America, Inc.
Decision Date2018-04-02
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC Fuji Direct is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2018-04-02 under approval number K172382. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC Fuji Direct?

GC Fuji Direct is a medical device that received FDA 510(k) clearance on 2018-04-02. It is manufactured by GC America, Inc.. The 510(k) number is K172382.

When was GC Fuji Direct approved by the FDA?

GC Fuji Direct received FDA 510(k) clearance on 2018-04-02, under approval number K172382.

What company makes GC Fuji Direct?

GC Fuji Direct is manufactured by GC America, Inc..

What is the FDA product code for GC Fuji Direct?

The FDA product code for GC Fuji Direct is EMA.

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Related Devices (Code: EMA)

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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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