Disposable Radiofrequency Cannula
FDA 510(k) K253907 · Abbott Medical
510(k) numberK253907
Submission
- Device name
- Disposable Radiofrequency Cannula
- Applicant
- Abbott Medical
Plano, TX, US - Received
- December 5, 2025
- Decision date
- April 16, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K191293 | LCCS VC-S RF CannulaGXI · Traditional | Lccs Products Limited | 01/24/2020SE |
More from Lccs Products Limited
| 510(k) | Device | Decision |
|---|---|---|
| K262006 | EnSite X EP SystemDQK · Special | 07/15/2026SE |
| K261631 | Amplatzer TorqVue Exchange SystemDQY · Special | 06/17/2026SE |
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System…NQQ · Traditional | 04/24/2026SE |
| K260212 | EnSite X EP SystemDQK · Traditional | 04/20/2026SE |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/…DQY · Special | 03/13/2026SE |
| K252512 | Armada 14 NC PTA CatheterLIT · Traditional | 02/13/2026SE |
| K253516 | Assert-IQ (DM5100)MXD · Special | 12/18/2025SE |
| K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045)DQY · Traditional | 12/17/2025SE |
| K253232 | Seguin Annuloplasty RingKRH · Special | 10/29/2025SE |
| K250031 | Amplatzer GuidewireDQX · Traditional | 10/03/2025SE |
Questions and answers
When was Disposable Radiofrequency Cannula cleared by the FDA?
Disposable Radiofrequency Cannula (K253907) received a 510(k) decision of Substantially Equivalent on April 16, 2026, 132 days after the submission was received.
What is the product code of K253907?
The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.