# K093008: Halo Ablation Catheter, Model 90-9100

- Pathway: 510(k) (Traditional)
- Applicant: Barrx Medical, Incorporated
- Decided: Jan 8, 2010 after 102 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: 16 generations back to K943450 (1995). 39 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 54 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 1.
- K062723: HALO90 Coagulation Catheter, Barrx Medical, Incorporated (2006) Summary page 1.
- K083737: Halo Ablation Catheter, Barrx Medical, Incorporated (2009) Summary page 1.
- K051168: Barrx Halo 360 System, Model 1100C-115A, Barrx Medical, Incorporated (2005). Our reading of the summary gave K050168, FDA’s number for Langston Dual Lumen Pressure Monitoring Catheter (Vascular Solutions, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “HALO 360 Ablation Catheter”.
- K062225: Halo Coagulation Catheter, Barrx Medical, Incorporated (2006) Summary page 1.
- K083711: Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34, Barrx Medical, Incorporated (2009) Summary page 1.
- K013139: Stellartech Coagulation System, Stellartech Research Corp. (2001) Summary page 1.
- K042909: Stellartech Coagulation System, Models 1100C-115A & 1100C-230A, Stellartech Research Corp. (2004) Summary page 1.
- K050831: Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230A, Stellartech Research Corp. (2005) Summary page 1.
- K970278: Microvasive Gold Probe, Boston Scientific Corp (1997) Summary page 1.
- K982289: Heat Probe Unit Hpu-20, Heat Probe CD-110##/120##, Olympus America, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K213627: RF Vapor System (2021), 2 descendants of its own
- K241271: Aqua Medical RF Vapor Ablation System (2024), 1 descendant of its own

## Indications for use
The HALO 90 System (including HALO 90 Ablation Catheter model 90-9100 and HALO 90 Energy Generator model 90-9000) 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, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).

Source page: https://510kreport.com/device/K093008
Methodology: https://510kreport.com/methodology