Cleared Special

K253877 - StimTrial Neuromodulation System

K253877 is an FDA 510(k) clearance for StimTrial Neuromodulation System, manufactured by Bioventus, LLC. The device is a Class 2 Neurology device with product code GZF cleared through the Special 510(k) pathway after a 265-day FDA review.

K253877 · Bioventus, LLC · Neurology device
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Aug 2026
Decision
265d
Days
Class 2
Risk

K253877 is an FDA 510(k) clearance for the StimTrial Neuromodulation System. Classified as Stimulator, Peripheral Nerve, Implanted (pain Relief) (product code GZF), Class II - Special Controls.

Submitted by Bioventus, LLC (Durham, US). The FDA issued a Cleared decision on August 26, 2026 after a review of 265 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bioventus, LLC devices

FDA 510(k) Submission Details - K253877

510(k) Number K253877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2025
Decision Date August 26, 2026
Days to Decision 265 days
Submission Type Special
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
117d slower than avg
Panel avg: 148d · This submission: 265d
Pathway characteristics
Modification to existing cleared device.

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 24
Devices cleared under the same product code (GZF) and FDA review panel - the closest regulatory comparables to K253877.
StimTrial Neuromodulation System
K243782 · Bioventus, LLC · Jul 2025
TalisMann Neuromodulation System
K243678 · Bioventus, LLC · Jul 2025
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
StimRouter Neuromodulation System
K211965 · Bioness, Inc. · Feb 2022