FDA 510(k)

Disposable Radiofrequency Cannula

K-Number: K253907 · 2026-04-16

Decision Date2026-04-16

Product CodeGXI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Disposable Radiofrequency Cannula is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K253907. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Radiofrequency Cannula?

Disposable Radiofrequency Cannula is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K253907.

When did Disposable Radiofrequency Cannula receive FDA 510(k) clearance?

Disposable Radiofrequency Cannula received FDA 510(k) clearance on 2026-04-16, under 510(k) number K253907.

Who is the listed applicant for Disposable Radiofrequency Cannula?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Radiofrequency Cannula?

The FDA product code for Disposable Radiofrequency Cannula is GXI.

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Related Devices (Code: GXI)

K251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICAL K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker Instruments K241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.K222281Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.