Cleared Traditional

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

K243782 · Bioventus, LLC · Neurology

Jul 2025

Decision

219d

Days

Class 2

Risk

K243782 is an FDA 510(k) clearance for the StimTrial Neuromodulation System. This device is classified as a Stimulator, Peripheral Nerve, Implanted (pain Relief) (Class II — Special Controls, product code GZF).

Submitted by Bioventus, LLC (Durham, US). The FDA issued a Cleared decision on July 16, 2025, 219 days after receiving the submission on December 9, 2024.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5870.

Submission Details

510(k) Number	K243782 FDA.gov
FDA Decision	Cleared 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