# K160360: Barrx FLEX RFA Energy Generator

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Apr 5, 2016 after 56 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: 18 generations back to K943450 (1995). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141357: Barrx Flex Rfa Energy Generator, Covidien Iic (2014) Summary page 5.

## 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/K160360
Methodology: https://510kreport.com/methodology