K250391 is an FDA 510(k) clearance for the Leksell Gamma Knife® (Elekta Esprit). This device is classified as a System, Radiation Therapy, Radionuclide (Class II - Special Controls, product code IWB).
Submitted by Elekta Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on July 2, 2025, 140 days after receiving the submission on February 12, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5750.
| 510(k) Number | K250391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2025 |
| Decision Date | July 02, 2025 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IWB - System, Radiation Therapy, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5750 |