K233162 is an FDA 510(k) clearance for the Freedom Peripheral Nerve Stimulator (PNS) System. Classified as Stimulator, Peripheral Nerve, Implanted (pain Relief) (product code GZF), Class II - Special Controls.
Submitted by Curonix (Pompano Beach, US). The FDA issued a Cleared decision on June 20, 2024 after a review of 267 days - an extended review cycle.
This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5870 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.
View all Curonix devices
NCT02729480
Completed
Interventional
Industry-sponsored
Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain
Multi-center, Prospective, Controlled, Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain
| Condition studied |
Facial Pain |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
|
| Sponsor |
Curonix LLC
(industry)
|
Started 2017-02-01
→
Primary completion 2022-02-01
→
Completed 2022-10-01
Primary outcome
Pain Score
Secondary outcome
Percentage change from baseline in VAS for facial pain
Study completed - no results published.
This trial concluded in 2022 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov