ScanNav Anatomy Peripheral Nerve Block
FDA 510(k) clearance K232787 · decided 2023-10-06
Clearance details
- K-number
- K232787
- Device name
- ScanNav Anatomy Peripheral Nerve Block
- Applicant
- Intelligent Ultrasound Limited
- Decision
- Substantially Equivalent
- Date received
- 2023-09-11
- Decision date
- 2023-10-06
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- QRG
- Device class
- 2
- Regulation number
- 868.1980
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Cardiff, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Nerveblox (K250818) | Smart Alfa Teknoloji San. Ve Tic. A.S. | 2025-08-15 |
| ScanNav Anatomy Peripheral Nerve Block (DEN220024) | Intelligent Ultrasound Limited | 2022-10-18 |
Recalls involving this device
No recalls on record reference this clearance.