Cleared Traditional

StimRouter Neuromodulation System

K211965 · Bioness, Inc. · Neurology
Feb 2022
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K211965 is an FDA 510(k) clearance for the StimRouter Neuromodulation System, a Stimulator, Peripheral Nerve, Implanted (pain Relief) (Class II — Special Controls, product code GZF), submitted by Bioness, Inc. (Valencia, US). The FDA issued a Cleared decision on February 23, 2022, 244 days after receiving the submission on June 24, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5870.

Submission Details

510(k) Number K211965 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2021
Decision Date February 23, 2022
Days to Decision 244 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZF — Stimulator, Peripheral Nerve, Implanted (pain Relief)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5870

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