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510(k) K240974

SPRINT PNS System by Spr Therapeutics, Inc. — Product Code SCN

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.

Other clearances by Spr Therapeutics, Inc.

  • K223306 — SPRINT Peripheral Nerve Stimulation (PNS) System (January 25, 2023)
  • K211801 — SPRINT PNS System (October 13, 2021)
  • K202660 — SPRINT PNS System (January 22, 2021)
  • K181422 — SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Sti (July 31, 2018)
  • K170902 — Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure (June 26, 2017)
  • K161154 — Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and A (July 23, 2016)