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FDA 510(k)

DEX Device

K-Number: K191878 · 2021-01-29

ApplicantDex Surgical
Decision Date2021-01-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEX Device is a medical device manufactured by Dex Surgical. It received FDA 510(k) clearance on 2021-01-29 under approval number K191878. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEX Device?

DEX Device is a medical device that received FDA 510(k) clearance on 2021-01-29. It is manufactured by Dex Surgical. The 510(k) number is K191878.

When was DEX Device approved by the FDA?

DEX Device received FDA 510(k) clearance on 2021-01-29, under approval number K191878.

What company makes DEX Device?

DEX Device is manufactured by Dex Surgical.

What is the FDA product code for DEX Device?

The FDA product code for DEX Device is GEI.

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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.

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