# K062441: Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010; Footswitch, Model 90-9020

- Pathway: 510(k) (Traditional)
- Applicant: Barrx Medical, Incorporated
- Decided: Nov 14, 2006 after 85 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: 14 generations back to K943450 (1995). 32 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060169: Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation Catheter, Models 2200-115A, 1520F, Barrx Medical, Incorporated (2006) Summary page 2.
- 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
- K092487: Haloflex Energy Generator, Models 1190A-115A and 1190A-230A (2009), 2 descendants of its own
- K141357: Barrx Flex Rfa Energy Generator (2014), 1 descendant of its own
- K160360: Barrx FLEX RFA Energy Generator (2016), 0 descendants of its own

## Indications for use
The HALO 90 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/K062441
Methodology: https://510kreport.com/methodology