K233162
- 510(k) number
- K233162
- Device name
- Freedom Peripheral Nerve Stimulator (PNS) System
- Applicant
- Curonix FL · US
- Product code
- GZF — Stimulator, Peripheral Nerve, Implanted (Pain Relief
- Decision date
- 2024-06-20
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K233162.pdf
Official FDA record: K233162
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.