# K082202: HALO360 Energy Generator, Models 1100C-115B and 1100C-230B

- Pathway: 510(k) (Special)
- Applicant: Barrx Medical, Incorporated
- Decided: Oct 8, 2008 after 64 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.
No later device cites it as a predicate yet.
0 of 32 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.

## Indications for use
The HALO 360 Energy Generator 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/K082202
Methodology: https://510kreport.com/methodology