Barrx Flex RFA Energy Generator

by Covidien Iic

510(k) K141357

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K141357↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK141357	Date21 Aug 2014Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K141357
FDA Product Code: GEI

Device Class: Class II
Regulation: 21 CFR Part 878.4400
Advisory Committee: General, Plastic Surgery
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Barrx Flex RFA Energy Generator is a bipolar radiofrequency generator intended for gastrointestinal tissue ablation. It delivers controlled radiofrequency energy to ablate diseased tissue within the GI tract, providing precise depth and uniformity of ablation.

The device was cleared through the FDA 510(k) pathway on August 21, 2014 and is classified as a Class 2 medical device under product code GEI (K141357). It is manufactured by Covidien Iic in Mansfield, MA, United States, and is supplied as a single unit without additional accessories noted.