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FDA 510(k)

Barrx SB RFA Endoscopic Catheter

K-Number: K173559 · 2018-01-18

ApplicantCovidien, LLC
Decision Date2018-01-18
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Barrx SB RFA Endoscopic Catheter is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2018-01-18 under approval number K173559. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Barrx SB RFA Endoscopic Catheter?

Barrx SB RFA Endoscopic Catheter is a medical device that received FDA 510(k) clearance on 2018-01-18. It is manufactured by Covidien, LLC. The 510(k) number is K173559.

When was Barrx SB RFA Endoscopic Catheter approved by the FDA?

Barrx SB RFA Endoscopic Catheter received FDA 510(k) clearance on 2018-01-18, under approval number K173559.

What company makes Barrx SB RFA Endoscopic Catheter?

Barrx SB RFA Endoscopic Catheter is manufactured by Covidien, LLC.

What is the FDA product code for Barrx SB RFA Endoscopic Catheter?

The FDA product code for Barrx SB RFA Endoscopic Catheter is KNS.

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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.