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510(k) K233162

Freedom Peripheral Nerve Stimulator (PNS) System by Curonix — Product Code GZF

K233162 is an FDA 510(k) premarket notification submitted by Curonix for the device "Freedom Peripheral Nerve Stimulator (PNS) System". The FDA issued a decision of Substantially Equivalent on June 20, 2024. The device falls under product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5870.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2024
Date Received
September 27, 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 for product code GZF

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  • K243678 — TalisMann Neuromodulation System (July 3, 2025)
  • K232415 — Nalu Neurostimulation System for Peripheral Nerve Stimulation (August 21, 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)

FDA data resources