510(k) K240974
K240974 is an FDA 510(k) premarket notification submitted by Spr Therapeutics, Inc. for the device "SPRINT PNS System". The FDA issued a decision of Substantially Equivalent on April 14, 2026. The device falls under product code SCN (Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief), a Class II device regulated under 21 CFR 882.5870. Spr Therapeutics, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2026
- Date Received
- April 10, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5870
- Review Panel
- NE
- Submission Type
A temporarily implanted peripheral nerve stimulation system for sustained pain relief is a prescription device that uses an external electrical stimulator(s) and percutaneous electrode(s) to stimulate a peripheral nerve(s) to provide sustained pain relief after the end of treatment.