Cleared Traditional

Freedom Peripheral Nerve Stimulator (PNS) System

K233162 · Curonix · Neurology

Jun 2024

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K233162 is an FDA 510(k) clearance for the Freedom Peripheral Nerve Stimulator (PNS) System, a Stimulator, Peripheral Nerve, Implanted (pain Relief) (Class II — Special Controls, product code GZF), submitted by Curonix (Pompano Beach, US). The FDA issued a Cleared decision on June 20, 2024, 267 days after receiving the submission on September 27, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5870.

Submission Details

510(k) Number	K233162 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2023
Decision Date	June 20, 2024
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF