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FDA 510(k)

Barrx Anorectal RFA Wand

K-Number: K162802 · 2017-01-24

ApplicantCovidien, LLC
Decision Date2017-01-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Barrx Anorectal RFA Wand is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2017-01-24 under 510(k) number K162802. 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 Anorectal RFA Wand?

Barrx Anorectal RFA Wand is a medical device that received FDA 510(k) clearance on 2017-01-24. The listed applicant is Covidien, LLC. The 510(k) number is K162802.

When did Barrx Anorectal RFA Wand receive FDA 510(k) clearance?

Barrx Anorectal RFA Wand received FDA 510(k) clearance on 2017-01-24, under 510(k) number K162802.

Who is the listed applicant for Barrx Anorectal RFA Wand?

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 Anorectal RFA Wand?

The FDA product code for Barrx Anorectal RFA Wand 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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