Cleared Traditional

K243782 - StimTrial Neuromodulation System (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243782 · Bioventus, LLC · Neurology device
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Jul 2025
Decision
219d
Days
Class 2
Risk

K243782 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 July 16, 2025 after a review of 219 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 Bioventus, LLC devices

Submission Details

510(k) Number K243782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2024
Decision Date July 16, 2025
Days to Decision 219 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
71d slower than avg
Panel avg: 148d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 23
Devices cleared under the same product code (GZF) and FDA review panel - the closest regulatory comparables to K243782.
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
Neuspera Neurostimulation System (NNS)
K202781 · Neuspera Medical, Inc. · Aug 2021