SPRINT PNS System
FDA 510(k) clearance K240974 · decided 2026-04-14
Clearance details
- K-number
- K240974
- Device name
- SPRINT PNS System
- Applicant
- Spr Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-04-10
- Decision date
- 2026-04-14
- Days to decision
- 734 days
- Clearance type
- Traditional
- Product code
- SCN
- Device class
- 2
- Regulation number
- 882.5870
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.