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FDA 510(k)

Barrx FLEX RFA Energy Generator

K-Number: K160360 · 2016-04-05

ApplicantCovidien, LLC
Decision Date2016-04-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Barrx FLEX RFA Energy Generator is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2016-04-05 under 510(k) number K160360. 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 Barrx FLEX RFA Energy Generator?

Barrx FLEX RFA Energy Generator is a medical device that received FDA 510(k) clearance on 2016-04-05. The listed applicant is Covidien, LLC. The 510(k) number is K160360.

When did Barrx FLEX RFA Energy Generator receive FDA 510(k) clearance?

Barrx FLEX RFA Energy Generator received FDA 510(k) clearance on 2016-04-05, under 510(k) number K160360.

Who is the listed applicant for Barrx FLEX RFA Energy Generator?

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

What is the FDA product code for Barrx FLEX RFA Energy Generator?

The FDA product code for Barrx FLEX RFA Energy Generator 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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