# K101111: Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200

- Pathway: 510(k) (Special)
- Applicant: Barrx Medical, Inc.
- Decided: Jun 18, 2010 after 58 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K943450 (1995). 40 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 42 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.
- K062723: HALO90 Coagulation Catheter, Barrx Medical, Incorporated (2006) Summary page 2.
- K083737: Halo Ablation Catheter, Barrx Medical, Incorporated (2009) Summary page 2.
- K093008: Halo Ablation Catheter, Model 90-9100, Barrx Medical, Incorporated (2010) Summary page 2.

## Most influential descendants
- K120431: HALO90 Ultra Ablation Catheter (2012), 0 descendants of its own

## Recalls of this device
- May 25, 2011 · Not classified · Z-2745-2011: Complaints of malfunction of the HALO ULTRA Ablation Catheter related to the device pivot mechanism's inability to return the electrode cap to a flat neutral position.

## Indications for use
The HALO90 ULTRA Ablation Catheter model 90-9200 (when used with HALOFLEX 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, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).

Source page: https://510kreport.com/device/K101111
Methodology: https://510kreport.com/methodology