# K141357: Barrx Flex Rfa Energy Generator

- Pathway: 510(k) (Traditional)
- Applicant: Covidien Iic
- Decided: Aug 21, 2014 after 90 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: 17 generations back to K943450 (1995). 44 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092487: Haloflex Energy Generator, Models 1190A-115A and 1190A-230A, Barrx Medical, Incorporated (2009) Summary page 4.
- K093855: Halo 360 & Sizing Balloon, Model 3441C, Barrx Medical, Incorporated (2010) Summary page 4.
- K093008: Halo Ablation Catheter, Model 90-9100, Barrx Medical, Incorporated (2010) Summary page 4.

## Most influential descendants
- K160360: Barrx FLEX RFA Energy Generator (2016), 0 descendants of its own

## Indications for use
The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of soft tissue. The Barrx FLEX RFA 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/K141357
Methodology: https://510kreport.com/methodology