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FDA 510(k)

Disposable Radiofrequency Cannula

K-Number: K253907 · 2026-04-16

ApplicantABBOTT MEDICAL
Decision Date2026-04-16
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Disposable Radiofrequency Cannula is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-04-16 under approval 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. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K253907.

When was Disposable Radiofrequency Cannula approved by the FDA?

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

What company makes Disposable Radiofrequency Cannula?

Disposable Radiofrequency Cannula is manufactured by ABBOTT MEDICAL.

What is the FDA product code for Disposable Radiofrequency Cannula?

The FDA product code for Disposable Radiofrequency Cannula is GXI.

Related Clinical Trials

NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

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Related Devices (Code: GXI)

K163236COOLIEF Cooled Radiofrequency KitHalyard Health, Inc. K152642LCCS Disposable RF Electrode, LCCS Reusable RF ElectrodeLccs Products Limited K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems K170708OWL RF INSULATED CANNULAEDiros Technology, Inc. K163461Coolief* Cooled RF ProbeHalyard Health, 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.

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