Barrx SB RFA Endoscopic Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K173559

Identifiers

510(k) Number: K173559 FDA 510(k)
FDA Product Code: KNS FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.4300 FDA 510(k)
Regulation Number: 876.4300 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Barrx SB RFA Endoscopic Catheter is classified as an Electrosurgical, Endoscopic (With or Without Accessories) device, designed for radiofrequency ablation (RFA) within the gastrointestinal tract. It delivers controlled radiofrequency energy to target and ablate abnormal tissue, such as lesions or tumors, during endoscopic procedures.

This device is intended for single-use and is supplied sterile, requiring no additional preparation before use. It is compatible with standard endoscopic equipment and is regulated under FDA 510(k) clearance (K173559) as substantially equivalent to a legally marketed predecessor. The catheter is supplied in various sizes and configurations, as indicated by the associated registration numbers, and is intended for use in gastroenterology and urology settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Microsoft Word - Special 510k_Barrx SB RFA Catheter_Final.docx, Barrx SB RFA Endoscopic Catheter - healthcareequipment.org, Barrx™ channel RFA endoscopic catheter - Medtronic, Barrx SB RFA Endoscopic Catheter - Covidien | FDA Reference

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K173559	Class II	Active

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Manufacturer

Manufacturer: Covidien llc
FDA Applicant: Covidien, LLC

Sources (1)

FDA 510(k) K173559 24 fields · synced Sep 19, 2026