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FDA 510(k)

Soniquence Bipolar Electrodes

K-Number: K190336 · 2019-06-20

ApplicantSoniquence, LLC
Decision Date2019-06-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Soniquence Bipolar Electrodes is a medical device manufactured by Soniquence, LLC. It received FDA 510(k) clearance on 2019-06-20 under approval number K190336. 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 Soniquence Bipolar Electrodes?

Soniquence Bipolar Electrodes is a medical device that received FDA 510(k) clearance on 2019-06-20. It is manufactured by Soniquence, LLC. The 510(k) number is K190336.

When was Soniquence Bipolar Electrodes approved by the FDA?

Soniquence Bipolar Electrodes received FDA 510(k) clearance on 2019-06-20, under approval number K190336.

What company makes Soniquence Bipolar Electrodes?

Soniquence Bipolar Electrodes is manufactured by Soniquence, LLC.

What is the FDA product code for Soniquence Bipolar Electrodes?

The FDA product code for Soniquence Bipolar Electrodes is GEI.

Related Clinical Trials

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Other Devices by Soniquence, LLC

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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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