# K083711: Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34

- Pathway: 510(k) (Special)
- Applicant: Barrx Medical, Incorporated
- Decided: Feb 2, 2009 after 49 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: 15 generations back to K943450 (1995). 35 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071543: HALO360' Coagulation Catheter, Barrx Medical, Incorporated (2007) Summary page 2.
- K062723: HALO90 Coagulation Catheter, Barrx Medical, Incorporated (2006) Summary page 2.

## Most influential descendants
- 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
- K211282: Aqua Medical RF Vapor System (2021), 3 descendants of its own
- K093855: Halo 360 & Sizing Balloon, Model 3441C (2010), 3 descendants of its own

## Indications for use
The HALO360+ Ablation 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, and Angiodysplasia.

Source page: https://510kreport.com/device/K083711
Methodology: https://510kreport.com/methodology