510(k) K250818
K250818 is an FDA 510(k) premarket notification submitted by Smart Alfa Teknoloji San. Ve Tic. A.S. for the device "Nerveblox". The FDA issued a decision of Substantially Equivalent on August 15, 2025. The device falls under product code QRG (Ultrasound Guided Nerve Block Assist), a Class II device regulated under 21 CFR 868.1980. Smart Alfa Teknoloji San. Ve Tic. A.S. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2025
- Date Received
- March 18, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasound Guided Nerve Block Assist
- Device Class
- Class II
- Regulation Number
- 868.1980
- Review Panel
- AN
- Submission Type
This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.