# K130623: Barrx Channel Rfa Endoscopic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Jul 26, 2013 after 140 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: 18 generations back to K943450 (1995). 41 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112454: HALO60 Ablation Catheter, Barrx Medical, Inc. (2012) Summary page 1.
- K093008: Halo Ablation Catheter, Model 90-9100, Barrx Medical, Incorporated (2010) Summary page 1.

## Most influential descendants
- K173559: Barrx SB RFA Endoscopic Catheter (2018), 0 descendants of its own

## Indications for use
The Barrx Channel 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/K130623
Methodology: https://510kreport.com/methodology