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FDA 510(k)

Soniquence Reusable Bipolar Cable

K-Number: K211946 · 2021-07-16

ApplicantSoniquence, LLC
Decision Date2021-07-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Soniquence Reusable Bipolar Cable is the device name listed in this FDA 510(k) record. The listed applicant is Soniquence, LLC. It received FDA 510(k) clearance on 2021-07-16 under 510(k) 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. The listed applicant is Soniquence, LLC. The 510(k) number is K211946.

When did Soniquence Reusable Bipolar Cable receive FDA 510(k) clearance?

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

Who is the listed applicant for Soniquence Reusable Bipolar Cable?

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

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

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

Other records listing Soniquence, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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