FDA.report

510(k) K233162

Device
Freedom Peripheral Nerve Stimulator (PNS) System
Applicant
Curonix
510(k) number
K233162
Product code
GZF
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-20
Date received
2023-09-27
Regulation
882.5870
Classification name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Hailey Rooney
Address
1310 Park Central Blvd. S Pompano Beach FL US 33064 33064

FDA Registration Numbers

Source Documents

510(k) summary PDF

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