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FDA 510(k)

MEDDUSA BIPOLAR SYSTEM

K-Number: K130110 · 2013-10-08

ApplicantElliquence, LLC
Decision Date2013-10-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDDUSA BIPOLAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Elliquence, LLC. It received FDA 510(k) clearance on 2013-10-08 under 510(k) number K130110. 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 MEDDUSA BIPOLAR SYSTEM?

MEDDUSA BIPOLAR SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-08. The listed applicant is Elliquence, LLC. The 510(k) number is K130110.

When did MEDDUSA BIPOLAR SYSTEM receive FDA 510(k) clearance?

MEDDUSA BIPOLAR SYSTEM received FDA 510(k) clearance on 2013-10-08, under 510(k) number K130110.

Who is the listed applicant for MEDDUSA BIPOLAR SYSTEM?

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 MEDDUSA BIPOLAR SYSTEM?

The FDA product code for MEDDUSA BIPOLAR SYSTEM 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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