Vaxiom Family of RF Lesion Probes & Elec
FDA 510(k) K802243 · Progress Mankind Technology
510(k) numberK802243
Submission
- Device name
- Vaxiom Family of RF Lesion Probes & Elec
- Applicant
- Progress Mankind Technology
Hopkins, MN, US - Received
- September 16, 1980
- Decision date
- November 12, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K253907 | Disposable Radiofrequency CannulaGXI · Traditional | Abbott Medical | 04/16/2026SE |
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| 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 |
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| K834047 | Pmt-Halo/Orthopedic Jacket SystemHAX · Traditional | 02/17/1984SE |
| K831329 | PMT Vaxiom Stereotactic Sys #FX001HAW · Traditional | 06/15/1983SE |
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Questions and answers
When was Vaxiom Family of RF Lesion Probes & Elec cleared by the FDA?
Vaxiom Family of RF Lesion Probes & Elec (K802243) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 57 days after the submission was received.
What is the product code of K802243?
The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.