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FDA 510(k)

SURGIMAX/ SURGIMAX PLUS

K-Number: K100390 · 2010-08-25

ApplicantElliquence, LLC
Decision Date2010-08-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGIMAX/ SURGIMAX PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Elliquence, LLC. It received FDA 510(k) clearance on 2010-08-25 under 510(k) number K100390. 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 SURGIMAX/ SURGIMAX PLUS?

SURGIMAX/ SURGIMAX PLUS is a medical device that received FDA 510(k) clearance on 2010-08-25. The listed applicant is Elliquence, LLC. The 510(k) number is K100390.

When did SURGIMAX/ SURGIMAX PLUS receive FDA 510(k) clearance?

SURGIMAX/ SURGIMAX PLUS received FDA 510(k) clearance on 2010-08-25, under 510(k) number K100390.

Who is the listed applicant for SURGIMAX/ SURGIMAX PLUS?

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 SURGIMAX/ SURGIMAX PLUS?

The FDA product code for SURGIMAX/ SURGIMAX PLUS is GEI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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