Flex RFA Energy Generator


Product Overview

Flex RFA Energy Generator
Barrx - 1190A-230A-01


Device Description

A noninvasive, electrically-powered device designed to generate radio-frequency (RF) electrical current to create heat in the gastrointestinal tract (e.g., oesophagus, stomach, rectum, anus) via a dedicated endoscopic electrode/catheter (not included) for focal ablation; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes controls and display.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: GEI

Device Name: Electrosurgical, Cutting & Coagulation & Accessories

Device Class: 2

Physical State: N/A

Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 878.4400

Third Party Flag: Y

Medical Specialty: SU


Device Identifiers

Device Id: 10884521660694

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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