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510(k) K232415

Nalu Neurostimulation System for Peripheral Nerve Stimulation by Boston Scientific Neuromodulation — Product Code GZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2024
Date Received
August 11, 2023
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 Boston Scientific Neuromodulation

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  • K221376 — Nalu Neurostimulation System (June 10, 2022)
  • K203547 — Nalu Neurostimulation System (March 25, 2021)
  • K202274 — Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimula (November 9, 2020)
  • K201618 — Nalu Neurostimulation SCS system (July 15, 2020)
  • K190960 — Nalu Lead Blank (50cm) (July 11, 2019)
  • K183579 — Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimul (March 29, 2019)
  • K183047 — Nalu Neurostimulation System (March 22, 2019)

Other clearances for product code GZF

  • K243782 — StimTrial Neuromodulation System (July 16, 2025)
  • K243678 — TalisMann Neuromodulation System (July 3, 2025)
  • 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)
  • K191435 — IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4 (September 6, 2019)