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FDA 510(k)

Genistrong

K-Number: K180836 · 2018-04-18

ApplicantGenicon, Inc.
Decision Date2018-04-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Genistrong is a medical device manufactured by Genicon, Inc.. It received FDA 510(k) clearance on 2018-04-18 under approval number K180836. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Genistrong?

Genistrong is a medical device that received FDA 510(k) clearance on 2018-04-18. It is manufactured by Genicon, Inc.. The 510(k) number is K180836.

When was Genistrong approved by the FDA?

Genistrong received FDA 510(k) clearance on 2018-04-18, under approval number K180836.

What company makes Genistrong?

Genistrong is manufactured by Genicon, Inc..

What is the FDA product code for Genistrong?

The FDA product code for Genistrong is GCJ.

Other Devices by Genicon, Inc.

K162059EZEE RETRIEVAL K171752X-SURGE K181791SIMPLYSTRONG, SIMPLYEZEE K180579Ezee Retrieval K190168Aquas Probes

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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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