RF Cannula

FDA 510(k) K241367 · Shanghai Samedical & Plastic Instruments Co., Ltd.

Substantially Equivalent

510(k) numberK241367

Submission

Device name
RF Cannula
Applicant
Shanghai Samedical & Plastic Instruments Co., Ltd.
Shanghai, CN
Received
May 14, 2024
Decision date
January 23, 2025
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

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K253907Disposable Radiofrequency CannulaGXI · Traditional Abbott Medical04/16/2026SE
K251802STAR RF Ablation SystemGXI · Traditional Merit Medical Systems, Inc.02/13/2026SE
K251243OneRF Trigeminal Nerve Radiofrequency ProbesGXI · Traditional Neuroone Medical Technologies Corp.08/15/2025SE
K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)GXI · Traditional Abbott Medical05/27/2025SE
K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN…GXI · Traditional Stryker Instruments05/15/2025SE
K222281Intracept Intraosseous Nerve Ablation SystemGXI · Traditional Relievant Medsystems, Inc.10/26/2022SE
K213836Intracept Intraosseous Nerve Ablation SystemGXI · Traditional Relievant Medsystems, Inc.03/11/2022SE
K203066COOLIEF Cooled Radiofrequency Kit AdvancedGXI · Traditional Avanos Medical, Inc.12/22/2020SE
K190259Vesta RF CannulaGXI · Special Biomerics02/07/2020SE
K191293LCCS VC-S RF CannulaGXI · Traditional Lccs Products Limited01/24/2020SE

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Questions and answers

When was RF Cannula cleared by the FDA?

RF Cannula (K241367) received a 510(k) decision of Substantially Equivalent on January 23, 2025, 254 days after the submission was received.

What is the product code of K241367?

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