# K051168: Barrx Halo 360 System, Model 1100C-115A

- Pathway: 510(k) (Traditional)
- Applicant: Barrx Medical, Incorporated
- Decided: Jun 29, 2005 after 55 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
No predicates in its family tree.
39 later devices descend from it; 9 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stellartech Coagulation System 2: named in the summary without a submission number

## Most influential descendants
- K060169: Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation Catheter, Models 2200-115A, 1520F (2006), 29 descendants of its own
- K062723: HALO90 Coagulation Catheter (2006), 26 descendants of its own
- K083737: Halo Ablation Catheter (2009), 22 descendants of its own
- K062225: Halo Coagulation Catheter (2006), 20 descendants of its own
- K071543: HALO360' Coagulation Catheter (2007), 19 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/K051168
Methodology: https://510kreport.com/methodology