# K062225: Halo Coagulation Catheter

- Pathway: 510(k) (Special)
- Applicant: Barrx Medical, Incorporated
- Decided: Aug 28, 2006 after 26 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: 13 generations back to K943450 (1995). 31 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051168: Barrx Halo 360 System, Model 1100C-115A, Barrx Medical, Incorporated (2005) Summary page 2.
- K050831: Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230A, Stellartech Research Corp. (2005) Summary page 2.

## Most influential descendants
- K071543: HALO360' Coagulation Catheter (2007), 19 descendants of its own
- K083711: Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 (2009), 17 descendants of its own
- K093008: Halo Ablation Catheter, Model 90-9100 (2010), 14 descendants of its own
- K183595: Aqua Medical RF Vapor System (2019), 4 descendants of its own
- K112454: HALO60 Ablation Catheter (2012), 4 descendants of its own

## Indications for use
The HALO 360 Coagulation System 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, and Angiodysplasia.

Source page: https://510kreport.com/device/K062225
Methodology: https://510kreport.com/methodology