FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The LeVeen Needle Electrode is intended to be used in conjunction with a RadioTherapeutics Corporation radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the LeVeen Needle Electrode. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter emphasizes that the effectiveness of this device for use in the treatment of liver cancer or liver disease (i.e., improved clinical outcomes) has not been established.

Therefore, I cannot provide the requested information. The document explicitly states that clinical outcomes or effectiveness for specific diseases have not been established, meaning the studies proving device performance against acceptance criteria for clinical effectiveness either don't exist or were not presented or deemed sufficient by the FDA for this clearance.

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K Number

K000032

Device Name

LEVEEN NEEDLE ELECTRODE

Manufacturer

RADIOTHERAPEUTICS CORP.

Date Cleared

2000-03-30

(85 days)

Product Code