LCCS VC-S RF Cannula
FDA 510(k) K191293 · Lccs Products Limited
510(k) numberK191293
Submission
- Device name
- LCCS VC-S RF Cannula
- Applicant
- Lccs Products Limited
Hong Kong, CN - Received
- May 14, 2019
- Decision date
- January 24, 2020
- 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 |
|---|---|---|---|
| K253907 | Disposable Radiofrequency CannulaGXI · Traditional | Abbott Medical | 04/16/2026SE |
| 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 |
More from Biomerics
| 510(k) | Device | Decision |
|---|---|---|
| K152642 | LCCS Disposable RF Electrode, LCCS Reusable RF ElectrodeGXI · Traditional | 08/26/2016SE |
| K131006 | Anesthesia Conduction NeedlesBSP · Traditional | 12/06/2013SE |
| K132136 | Single Use Grounding PadGEI · Traditional | 09/06/2013SE |
| K112231 | LCCS Insulated Spinal Needle (RF Cannula)GXI · Traditional | 08/19/2011SE |
Questions and answers
When was LCCS VC-S RF Cannula cleared by the FDA?
LCCS VC-S RF Cannula (K191293) received a 510(k) decision of Substantially Equivalent on January 24, 2020, 255 days after the submission was received.
What is the product code of K191293?
The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.