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510(k) K240974

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

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
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Device Class
Class II
Regulation Number
882.5870
Review Panel
NE
Submission Type

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)

Other clearances for product code GZF

  • K243782 — StimTrial Neuromodulation System (July 16, 2025)
  • K243678 — TalisMann Neuromodulation System (July 3, 2025)
  • K232415 — Nalu Neurostimulation System for Peripheral Nerve Stimulation (August 21, 2024)
  • K233162 — Freedom Peripheral Nerve Stimulator (PNS) System (June 20, 2024)
  • K221303 — Neuspera Nuity System (April 11, 2023)
  • K211965 — StimRouter Neuromodulation System (February 23, 2022)
  • K202781 — Neuspera Neurostimulation System (NNS) (August 27, 2021)
  • K200848 — Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit (August 14, 2020)
  • K200482 — StimRouter Neuromodulation System (March 27, 2020)
  • K190047 — StimRouter Neuromodulation System (October 31, 2019)