StimTrial Neuromodulation System

Q: What is the product code of K243782?

The FDA product code is GZF – Stimulator, Peripheral Nerve, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5870.

FDA 510(k) K243782 · Bioventus, LLC

Substantially Equivalent

510(k) numberK243782

Submission

Device name: StimTrial Neuromodulation System
Applicant: Bioventus, LLC
Durham, NC, US
Received: December 9, 2024
Decision date: July 16, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GZF – Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5870
Specialty: Neurology
Implant: Yes

Other 510(k)s with product code GZF

510(k)	Device	Applicant	Decision
K253877	StimTrial Neuromodulation SystemGZF · Special	Bioventus, LLC	08/26/2026SE
K243678	TalisMann Neuromodulation SystemGZF · Traditional	Bioventus, LLC	07/03/2025SE
K232415	Nalu Neurostimulation System for Peripheral Nerve StimulationGZF · Traditional	Boston Scientific Neuromodulation	08/21/2024SE
K233162	Freedom Peripheral Nerve Stimulator (PNS) SystemGZF · Traditional	Curonix	06/20/2024SE
K221303	Neuspera Nuity SystemGZF · Traditional	Neuspera Medical, Inc.	04/11/2023SE
K211965	StimRouter Neuromodulation SystemGZF · Traditional	Bioness, Inc.	02/23/2022SE
K202781	Neuspera Neurostimulation System (NNS)GZF · Traditional	Neuspera Medical, Inc.	08/27/2021SE
K200848	Stimulator, Stimulator Kit, External Transmitter, External Transmitter KitGZF · Traditional	Micron Medical Corporation	08/14/2020SE
K200482	StimRouter Neuromodulation SystemGZF · Special	Bioness, Inc.	03/27/2020SE
K190047	StimRouter Neuromodulation SystemGZF · Traditional	Bioness, Inc.	10/31/2019SE

More from Bioness, Inc.

510(k)	Device	Decision
K253877	StimTrial Neuromodulation SystemGZF · Special	08/26/2026SE
K243678	TalisMann Neuromodulation SystemGZF · Traditional	07/03/2025SE
K233368	Allograft Delivery Device (OFAC-C)FMF · Traditional	06/25/2024SE
K233490	SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyMQV · Traditional	12/05/2023SE
K193513	SIGNAFUSE Bioactive Bone GraftMQV · Traditional	06/18/2020SE
K162860	MCS Bone GraftMQV · Traditional	02/13/2017SE

Questions and answers

When was StimTrial Neuromodulation System cleared by the FDA?

StimTrial Neuromodulation System (K243782) received a 510(k) decision of Substantially Equivalent on July 16, 2025, 219 days after the submission was received.

What is the product code of K243782?

The FDA product code is GZF – Stimulator, Peripheral Nerve, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5870.