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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 the device name listed in this FDA 510(k) record. The listed applicant is Elliquence, LLC. It received FDA 510(k) clearance on 2017-05-03 under 510(k) 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. The listed applicant is Elliquence, LLC. The 510(k) number is K170107.

When did Surgi Max Ultra receive FDA 510(k) clearance?

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

Who is the listed applicant for Surgi Max Ultra?

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

What is the FDA product code for Surgi Max Ultra?

The FDA product code for Surgi Max Ultra is GEI.

Other records listing Elliquence, LLC as applicant

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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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