Disposable Radiofrequency Cannula— 510(k) K253907
Substantially EquivalentABBOTT MEDICAL
FDA 510(k) clearance K253907 for Disposable Radiofrequency Cannula, Substantially Equivalent on 2026-04-16. Applicant: ABBOTT MEDICAL. Device class: 2.
Summary
Abbott Medical's Disposable Radiofrequency Cannula is filed under product code GXI (Probe, Radiofrequency Lesion). The name is generic.
Class II, 21 CFR 882.4725. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Abbott Medical filed from Plano, Texas. The decision came 132 calendar days after FDA received it (December 5, 2025 to April 16, 2026).
Clearance details
- Applicant
- ABBOTT MEDICAL
- Product code
- Product code GXI
- Device class
- Class 2
- Regulation
- 21 CFR 882.4725
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plano, TX, US
Recent devices under product code GXI
view allMore clearances from ABBOTT MEDICAL
view allAdverse events under product code GXI
product code GXI- Death
- 3
- Injury
- 171
- Total
- 174
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.