FDA 510(k)

Soniquence Reusable Bipolar Cable

K-Number: K211946 · 2021-07-16

Decision Date2021-07-16

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Soniquence Reusable Bipolar Cable is a medical device manufactured by Soniquence, LLC. It received FDA 510(k) clearance on 2021-07-16 under approval number K211946. 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 Reusable Bipolar Cable?

Soniquence Reusable Bipolar Cable is a medical device that received FDA 510(k) clearance on 2021-07-16. It is manufactured by Soniquence, LLC. The 510(k) number is K211946.

When was Soniquence Reusable Bipolar Cable approved by the FDA?

Soniquence Reusable Bipolar Cable received FDA 510(k) clearance on 2021-07-16, under approval number K211946.

What company makes Soniquence Reusable Bipolar Cable?

Soniquence Reusable Bipolar Cable is manufactured by Soniquence, LLC.

What is the FDA product code for Soniquence Reusable Bipolar Cable?

The FDA product code for Soniquence Reusable Bipolar Cable is GEI.

Other Devices by Soniquence, LLC

K190336Soniquence Bipolar Electrodes K183611Soniquence RF Generator and Soniquence Electrodes K212222Soniquence Reusable 3 Button Fingerswitch Wand K220071Soniquence Reusable Neutral Plate K254220Reusable 3 Button Fingerswitch Wand

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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.