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510(k) K211965

StimRouter Neuromodulation System by Bioness, Inc. — Product Code GZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2022
Date Received
June 24, 2021
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 Bioness, Inc.

  • K200482 — StimRouter Neuromodulation System (March 27, 2020)
  • K200262 — L100 Go System (March 4, 2020)
  • K190047 — StimRouter Neuromodulation System (October 31, 2019)
  • K191587 — L360 Thigh System (September 12, 2019)
  • K190285 — L300 Go System (March 14, 2019)
  • K173682 — L300 Go System (March 9, 2018)
  • K162407 — L300 Go System (January 27, 2017)
  • K142432 — StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRo (February 20, 2015)
  • K123636 — H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE (May 1, 2013)
  • K122784 — NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3- (December 27, 2012)

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)
  • 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)
  • K191435 — IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4 (September 6, 2019)