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510(k) K181422

SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit by Spr Therapeutics, Inc. — Product Code NHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2018
Date Received
May 31, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain. Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a pens uses electrodes that are placed percutaneously to deliver stimulation,

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)
  • 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 NHI

  • K223306 — SPRINT Peripheral Nerve Stimulation (PNS) System (January 25, 2023)
  • K221425 — Primary Relief (September 13, 2022)
  • K220397 — ANSiStim-PP (May 12, 2022)
  • K213188 — Primary Relief (January 31, 2022)
  • K212859 — First Relief (December 20, 2021)
  • K211801 — SPRINT PNS System (October 13, 2021)
  • K202660 — SPRINT PNS System (January 22, 2021)
  • 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)
  • K061166 — DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM (August 15, 2006)