Stryker Venom Electrodes and Cannulae
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123178 FDA 510(k)
- FDA Product Code
- GXI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4725 FDA 510(k)
- Regulation Number
- 882.4725 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Stryker Venom Electrodes and Cannulae are radiofrequency lesion probes designed for neurological applications. These devices facilitate controlled tissue ablation to create lesions in nerve tissue, primarily for pain management procedures. They are categorized under Class II medical devices and are intended for use in radiofrequency ablation therapies.
These electrodes and cannulae are supplied sterile and intended for single-use. They are compatible with MRI environments and are available in multiple reference codes for different procedural requirements. Authorized under FDA 510(k) clearance (K123178), they are regulated under the U.S. Food and Drug Administration’s medical device classification system (regulation number 882.4725) and are distributed by Stryker Instruments, Instruments Division.
Frequently asked questions
What types of procedures are the Stryker Venom Electrodes and Cannulae designed for?
The Stryker Venom Electrodes and Cannulae are specifically designed for neurological applications, particularly to facilitate controlled tissue ablation and create lesions in nerve tissue. They are intended for use in radiofrequency ablation therapies, which are commonly employed in pain management procedures to target and disrupt specific nerve pathways.
Are the Stryker Venom Electrodes and Cannulae compatible with MRI environments?
Yes, the Stryker Venom Electrodes and Cannulae are explicitly stated to be compatible with MRI environments. This compatibility ensures they can be safely used in magnetic resonance imaging settings, which is important for procedures requiring imaging guidance or follow-up.
How are the Stryker Venom Electrodes and Cannulae supplied, and are they reusable?
The Stryker Venom Electrodes and Cannulae are supplied sterile and are intended for single-use only. This design ensures patient safety and reduces the risk of contamination or cross-infection, which is critical in sterile medical procedures.
What regulatory pathway was followed for the FDA clearance of these devices?
The Stryker Venom Electrodes and Cannulae were cleared through the FDA’s 510(k) pathway, specifically under a Traditional 510(k) review. The device was determined to be substantially equivalent to a legally marketed predicate and falls under the Neurology advisory committee category. The clearance number is K123178, and the regulatory classification is Class II under FDA regulation number 882.4725.
How many different reference codes or models are available for the Stryker Venom Electrodes and Cannulae?
The Stryker Venom Electrodes and Cannulae come in multiple reference codes, with over 50 distinct FEI numbers listed in the FDA database. These variations likely correspond to different sizes, lengths, or configurations to accommodate various procedural requirements in neurological radiofrequency ablation.
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: Venom cannula and electrode system - Stryker, MultiGen® 2 radiofrequency generator and Venom® cannula and ... - Stryker, STRYKER VENOM ELECTRODES AND CANNULAE by STRYKER INSTRUMENTS ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123178 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Instruments, Instruments Div.
Sources (1)
- FDA 510(k) K123178 24 fields · synced Sep 19, 2026