TalisMann Neuromodulation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243678 FDA 510(k)
- FDA Product Code
- GZF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5870 FDA 510(k)
- Regulation Number
- 882.5870 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TalisMann Neuromodulation System is a peripheral nerve stimulation device designed to reduce pain in patients with chronic pain of peripheral nerve origin. It is a permanent system that combines electric field conduction technology with an implanted pulse generator (IPG) to deliver gentle electrical pulses directly to the target peripheral nerve.
The system is supplied with components for both clinicians and patients, including the TalisMann Pulse Generator and Receiver, Implant Kit, Clinician Kit, and User Kit. It is classified as a class II medical device and regulated under product code GZF with regulation number 882.5870. The device has received FDA 510(k) clearance with the decision code SESE and is intended for use by trained clinicians.
Frequently asked questions
What is the TalisMann Neuromodulation System used for?
The TalisMann Neuromodulation System is designed to reduce pain in patients with chronic pain of peripheral nerve origin. It combines electric field conduction technology with an implanted pulse generator to deliver gentle electrical pulses directly to the target peripheral nerve.
What components are included with the TalisMann Neuromodulation System?
The system is supplied with components for both clinicians and patients, including the TalisMann Pulse Generator and Receiver, Implant Kit, Clinician Kit, and User Kit. These components are designed to support both the implantation procedure and ongoing patient use.
Is the TalisMann Neuromodulation System reusable or single-use?
The TalisMann Neuromodulation System is a permanent system that is implanted in the patient. It is not designed for single-use and is intended to provide long-term pain management through the implanted pulse generator.
What is the regulatory classification of the TalisMann Neuromodulation System?
The device is classified as a class II medical device and regulated under product code GZF with regulation number 882.5870. It has received FDA 510(k) clearance with the decision code SESE and is intended for use by trained clinicians.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pain Treatments - Bioventus, TalisMann - StimRouter, PDF TM © 2025 Bioventus - stimrouter.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243678 | Class II | Active |
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Manufacturer
- Manufacturer
- Bioventus Llc
- FDA Applicant
- Bioventus, LLC
Sources (1)
- FDA 510(k) K243678 24 fields · synced Sep 27, 2026