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FDA 510(k)

Surgi Max Ultra

K-Number: K170107 · 2017-05-03

ApplicantElliquence, LLC
Decision Date2017-05-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgi Max Ultra is a medical device manufactured by Elliquence, LLC. It received FDA 510(k) clearance on 2017-05-03 under approval number K170107. 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 Surgi Max Ultra?

Surgi Max Ultra is a medical device that received FDA 510(k) clearance on 2017-05-03. It is manufactured by Elliquence, LLC. The 510(k) number is K170107.

When was Surgi Max Ultra approved by the FDA?

Surgi Max Ultra received FDA 510(k) clearance on 2017-05-03, under approval number K170107.

What company makes Surgi Max Ultra?

Surgi Max Ultra is manufactured by Elliquence, LLC.

What is the FDA product code for Surgi Max Ultra?

The FDA product code for Surgi Max Ultra 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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