K250818 is an FDA 510(k) clearance for the Nerveblox. This device is classified as a Ultrasound Guided Nerve Block Assist (Class II - Special Controls, product code QRG).
Submitted by Smart Alfa Teknoloji San. Ve Tic. A.S. (Ankara, TR). The FDA issued a Cleared decision on August 15, 2025, 150 days after receiving the submission on March 18, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1980. This Device Provides Real-time Interpretation And Enhanced Visualization Of Live Ultrasound Images By Highlighting Anatomical Landmarks In Preparation For Performing Regional Anesthesia..
| 510(k) Number | K250818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2025 |
| Decision Date | August 15, 2025 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | QRG - Ultrasound Guided Nerve Block Assist |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1980 |
| Definition | This Device Provides Real-time Interpretation And Enhanced Visualization Of Live Ultrasound Images By Highlighting Anatomical Landmarks In Preparation For Performing Regional Anesthesia. |