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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 the device name listed in this FDA 510(k) record. The listed applicant is Genicon, Inc.. It received FDA 510(k) clearance on 2017-10-17 under 510(k) 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. The listed applicant is Genicon, Inc.. The 510(k) number is K171752.

When did X-SURGE receive FDA 510(k) clearance?

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

Who is the listed applicant for X-SURGE?

The FDA 510(k) record lists Genicon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-SURGE?

The FDA product code for X-SURGE is GEI.

Other records listing Genicon, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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