# K112454: HALO60 Ablation Catheter

- Pathway: 510(k) (Special)
- Applicant: Barrx Medical, Inc.
- Decided: Jan 5, 2012 after 133 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K943450 (1995). 40 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093008: Halo Ablation Catheter, Model 90-9100, Barrx Medical, Incorporated (2010) Summary page 1.
- K083737: Halo Ablation Catheter, Barrx Medical, Incorporated (2009) Summary page 3.
- K062723: HALO90 Coagulation Catheter, Barrx Medical, Incorporated (2006) Summary page 1.

## Most influential descendants
- K150251: Barrx Anorectal RFA Wand (2015), 1 descendant of its own
- K130623: Barrx Channel Rfa Endoscopic Catheter (2013), 1 descendant of its own
- K173559: Barrx SB RFA Endoscopic Catheter (2018), 0 descendants of its own
- K162802: Barrx Anorectal RFA Wand (2017), 0 descendants of its own

## Indications for use
The HALO60 Ablation Catheter (used with the HALOFLEX Energy Generator, model 1190A-115A) 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 (11P).

Source page: https://510kreport.com/device/K112454
Methodology: https://510kreport.com/methodology