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K Number
K242841
Device Name
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
Manufacturer
Abbott Medical
Date Cleared
2025-05-27

(250 days)

Product Code
GXI
Regulation Number
882.4725
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.4725 Radiofrequency lesion probe.

(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).