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510(k) K233162

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

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

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  • 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)