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FDA 510(k)

X-SURGE

K-Number: K171752 · 2017-10-17

ApplicantGenicon, Inc.
Decision Date2017-10-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

X-SURGE is a medical device manufactured by Genicon, Inc.. It received FDA 510(k) clearance on 2017-10-17 under approval number K171752. 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 X-SURGE?

X-SURGE is a medical device that received FDA 510(k) clearance on 2017-10-17. It is manufactured by Genicon, Inc.. The 510(k) number is K171752.

When was X-SURGE approved by the FDA?

X-SURGE received FDA 510(k) clearance on 2017-10-17, under approval number K171752.

What company makes X-SURGE?

X-SURGE is manufactured by Genicon, Inc..

What is the FDA product code for X-SURGE?

The FDA product code for X-SURGE 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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