Nerveblox
FDA 510(k) clearance K250818 · decided 2025-08-15
Clearance details
- K-number
- K250818
- Device name
- Nerveblox
- Applicant
- Smart Alfa Teknoloji San. Ve Tic. A.S.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-18
- Decision date
- 2025-08-15
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- QRG
- Device class
- 2
- Regulation number
- 868.1980
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Ankara, TR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Smart Alfa Teknoloji San. Ve Tic. A.S.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ScanNav Anatomy Peripheral Nerve Block (K232787) | Intelligent Ultrasound Limited | 2023-10-06 |
| ScanNav Anatomy Peripheral Nerve Block (DEN220024) | Intelligent Ultrasound Limited | 2022-10-18 |
Recalls involving this device
No recalls on record reference this clearance.