Soniquence Reusable 3 Button Fingerswitch Wand
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212222 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Soniquence Reusable 3-Button Fingerswitch Wand is a reusable device classified under the nomenclature category General, Plastic Surgery (Product Code: GEI). It functions as a handheld control interface designed to facilitate precise, ergonomic manipulation of ultrasound imaging systems, enabling operators to adjust settings with minimal hand movement and improved efficiency during procedures.
This device is intended for reusable clinical use and is supplied sterile or non-sterile as required by the surgical setting. It is not MRI-safe and must be used in environments where magnetic resonance imaging is not performed. The wand is authorized under FDA 510K clearance (K212222) and meets MDR requirements, ensuring compliance with regulatory standards for medical devices in the United States. Storage and handling follow standard reusable medical device protocols to maintain functionality and hygiene.
Frequently asked questions
What is the primary purpose of the Soniquence Reusable 3-Button Fingerswitch Wand in clinical settings?
The Soniquence Reusable 3-Button Fingerswitch Wand is designed as a handheld control interface to enhance precision and ergonomics during ultrasound imaging procedures. It allows operators to adjust settings with minimal hand movement, improving efficiency and reducing fatigue during use. Its classification under General, Plastic Surgery (Product Code: GEI) reflects its role as a reusable tool for manipulating imaging systems, not as a surgical instrument itself.
How should the Soniquence Reusable 3-Button Fingerswitch Wand be prepared for use in a sterile surgical environment?
The wand is supplied in both sterile and non-sterile versions to accommodate different clinical needs. If a sterile version is required, it should be handled according to standard sterile medical device protocols, ensuring it remains uncontaminated until use. The device’s reusable nature means it must be properly cleaned, disinfected, and stored between procedures to maintain hygiene and functionality.
Can the Soniquence Reusable 3-Button Fingerswitch Wand be used in areas where MRI machines are present?
No, the Soniquence Reusable 3-Button Fingerswitch Wand is explicitly not MRI-safe, meaning it should only be used in environments where magnetic resonance imaging is not performed. This restriction is critical to avoid potential interference or safety risks associated with MRI systems, which generate strong magnetic fields.
What storage and handling guidelines should be followed to maintain the wand’s functionality and cleanliness?
Since the wand is reusable, it must be stored and handled according to standard protocols for reusable medical devices. This includes cleaning, disinfecting, and inspecting it after each use to prevent contamination and ensure its buttons and controls remain functional. Proper storage—such as in a clean, dry environment—is also essential to avoid damage or degradation over time.
What regulatory pathways does the Soniquence Reusable 3-Button Fingerswitch Wand follow in the U.S. and internationally?
In the U.S., the wand is cleared through the FDA’s 510(k) pathway under clearance number K212222, with a decision classification of *Substantially Equivalent* (SESE) and reviewed by the Surgical, Urological, and Gastroenterological Devices (SU) advisory committee. Internationally, it complies with MDR (Medical Device Regulation) requirements, ensuring it meets EU regulatory standards for medical devices.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212222 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Soniquence, LLC
Sources (2)
- FDA 510(k) K212222 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026