Cleared Traditional

K211965 - StimRouter Neuromodulation System

K211965 is an FDA 510(k) clearance for StimRouter Neuromodulation System, manufactured by Bioness, Inc.. The device is a Class 2 Neurology device with product code GZF cleared through the Traditional 510(k) pathway after a 244-day FDA review.

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

K211965 is an FDA 510(k) clearance for the StimRouter Neuromodulation System. Classified as Stimulator, Peripheral Nerve, Implanted (pain Relief) (product code GZF), Class II - Special Controls.

Submitted by Bioness, Inc. (Valencia, US). The FDA issued a Cleared decision on February 23, 2022 after a review of 244 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 Bioness, Inc. devices

FDA 510(k) Submission Details - K211965

510(k) Number K211965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 148d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZF Device Classification - Class 2, Special Controls

Product Code GZF Stimulator, Peripheral Nerve, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZF Stimulator, Peripheral Nerve, Implanted (pain Relief)

All 20
Devices cleared under the same product code (GZF) and FDA review panel - the closest regulatory comparables to K211965.
Nalu Neurostimulation System for Peripheral Nerve Stimulation
K232415 · Boston Scientific Neuromodulation · Aug 2024
Freedom Peripheral Nerve Stimulator (PNS) System
K233162 · Curonix · Jun 2024
Neuspera Nuity System
K221303 · Neuspera Medical, Inc. · Apr 2023
Neuspera Neurostimulation System (NNS)
K202781 · Neuspera Medical, Inc. · Aug 2021
Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit
K200848 · Micron Medical Corporation · Aug 2020
StimRouter Neuromodulation System
K200482 · Bioness, Inc. · Mar 2020