FDA 510(k)

Barrx Anorectal RFA Wand

K-Number: K162802 · 2017-01-24

Decision Date2017-01-24

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Barrx Anorectal RFA Wand is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2017-01-24 under approval 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. It is manufactured by Covidien, LLC. The 510(k) number is K162802.

When was Barrx Anorectal RFA Wand approved by the FDA?

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

What company makes Barrx Anorectal RFA Wand?

Barrx Anorectal RFA Wand is manufactured by Covidien, LLC.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.