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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 the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2018-01-18 under 510(k) 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. The listed applicant is Covidien, LLC. The 510(k) number is K173559.

When did Barrx SB RFA Endoscopic Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Barrx SB RFA Endoscopic Catheter?

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 SB RFA Endoscopic Catheter?

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

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Related Devices (Code: KNS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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