SPRINT PNS System
FDA 510(k) K240974 · Spr Therapeutics, Inc.
510(k) numberK240974
Submission
- Device name
- SPRINT PNS System
- Applicant
- Spr Therapeutics, Inc.
Cleveland, OH, US - Received
- April 10, 2024
- Decision date
- April 14, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- SCN – Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5870
- Specialty
- Neurology
- Implant
- Yes
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.
More from Spr Therapeutics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K223306 | SPRINT Peripheral Nerve Stimulation (PNS) SystemNHI · Traditional | 01/25/2023SE |
| K211801 | SPRINT PNS SystemNHI · Traditional | 10/13/2021SE |
| K202660 | SPRINT PNS SystemNHI · Traditional | 01/22/2021SE |
| K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation…NHI · Traditional | 07/31/2018SE |
| K170902 | Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit…NHI · Traditional | 06/26/2017SE |
| K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…NHI · Traditional | 07/23/2016SE |
Questions and answers
When was SPRINT PNS System cleared by the FDA?
SPRINT PNS System (K240974) received a 510(k) decision of Substantially Equivalent on April 14, 2026, 734 days after the submission was received.
What is the product code of K240974?
The FDA product code is SCN – Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5870.