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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
116d slower than avg
Panel avg: 149d · 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
K253877 · StimTrial Neuromodulation System
Download PDF FDA Summary Bioventus, LLC