K240504 is an FDA 510(k) clearance for the PLASMA EDGE System. This device is classified as a Electrode, Electrosurgical, Active, Urological (Class II - Special Controls, product code FAS).
Submitted by Lamidey Noury Medical (Verrières Le Buisson, FR). The FDA issued a Cleared decision on June 12, 2024, 112 days after receiving the submission on February 21, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K240504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2024 |
| Decision Date | June 12, 2024 |
| Days to Decision | 112 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAS - Electrode, Electrosurgical, Active, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |