# K173559: Barrx SB RFA Endoscopic Catheter

- Pathway: 510(k) (Special)
- Applicant: Covidien, LLC
- Decided: Jan 18, 2018 after 62 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K943450 (1995). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130623: Barrx Channel Rfa Endoscopic Catheter, Covidien, LLC (2013) Summary page 4.

## Indications for use
Barrx™ SB RFA Endoscopic Catheter is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett’s Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).

Source page: https://510kreport.com/device/K173559
Methodology: https://510kreport.com/methodology