Stryker RF Electrodes and Cannulae

Q: What is the product code of K032406?

The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.

FDA 510(k) K032406 · Stryker Instruments

Substantially Equivalent

510(k) numberK032406

Submission

Device name: Stryker RF Electrodes and Cannulae
Applicant: Stryker Instruments
Kalamazoo, MI, US
Received: August 4, 2003
Decision date: April 1, 2004
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GXI – Probe, Radiofrequency Lesion
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4725
Specialty: Neurology

Other 510(k)s with product code GXI

510(k)	Device	Applicant	Decision
K253907	Disposable Radiofrequency CannulaGXI · Traditional	Abbott Medical	04/16/2026SE
K251802	STAR RF Ablation SystemGXI · Traditional	Merit Medical Systems, Inc.	02/13/2026SE
K251243	OneRF Trigeminal Nerve Radiofrequency ProbesGXI · Traditional	Neuroone Medical Technologies Corp.	08/15/2025SE
K242841	Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)GXI · Traditional	Abbott Medical	05/27/2025SE
K250213	OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN…GXI · Traditional	Stryker Instruments	05/15/2025SE
K241367	RF CannulaGXI · Traditional	Shanghai Samedical & Plastic Instruments Co., Ltd.	01/23/2025SE
K222281	Intracept Intraosseous Nerve Ablation SystemGXI · Traditional	Relievant Medsystems, Inc.	10/26/2022SE
K213836	Intracept Intraosseous Nerve Ablation SystemGXI · Traditional	Relievant Medsystems, Inc.	03/11/2022SE
K203066	COOLIEF Cooled Radiofrequency Kit AdvancedGXI · Traditional	Avanos Medical, Inc.	12/22/2020SE
K190259	Vesta RF CannulaGXI · Special	Biomerics	02/07/2020SE

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K250327	OptaBlate Radiofrequency (RF) Generator SystemGEI · Special	04/15/2025SE
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Questions and answers

When was Stryker RF Electrodes and Cannulae cleared by the FDA?

Stryker RF Electrodes and Cannulae (K032406) received a 510(k) decision of Substantially Equivalent on April 1, 2004, 241 days after the submission was received.

What is the product code of K032406?

The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.