K242841 is an FDA 510(k) clearance for the Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20). This device is classified as a Probe, Radiofrequency Lesion (Class II - Special Controls, product code GXI).
Submitted by Abbott Medical (Plano, US). The FDA issued a Cleared decision on May 27, 2025, 250 days after receiving the submission on September 19, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4725.
| 510(k) Number | K242841 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2024 |
| Decision Date | May 27, 2025 |
| Days to Decision | 250 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXI — Probe, Radiofrequency Lesion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4725 |