Identifiers
- 510(k) Number
- K212326 FDA 510(k)
- FDA Product Code
- GYB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1275 FDA 510(k)
- Regulation Number
- 882.1275 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AC Cream Conductive Paste is an electroconductive medium designed for use in electroencephalography (EEG) recordings. It facilitates electrical signal transmission between electrodes and skin, ensuring accurate and reliable EEG measurements by reducing impedance at the electrode-skin interface. This paste is specifically formulated to enhance conductivity while maintaining compatibility with cup electrodes.
Supplied in a recyclable jar, the AC Cream Conductive Paste is intended for single-use applications in clinical settings. It is dermatologically tested and free from parabens, dyes, and fragrances, ensuring minimal skin irritation. The product adheres to FDA 510(k) clearance (K212326) under the product code GYB, classified as Class II with Special Controls. It is not intended for reusable purposes and must be used in accordance with standard EEG procedures.
Frequently asked questions
What is the AC Cream Conductive Paste used for?
The AC Cream Conductive Paste is specifically designed for electroencephalography (EEG) recordings. It acts as an electroconductive medium to improve electrical signal transmission between electrodes and skin, ensuring accurate and reliable EEG measurements by minimizing impedance at the electrode-skin interface. This is critical for obtaining high-quality diagnostic data in clinical settings.
How is the AC Cream Conductive Paste supplied?
The AC Cream Conductive Paste is supplied in a recyclable jar, making it convenient for clinical use. Each jar is intended for single-use only, ensuring hygiene and reducing the risk of contamination. This aligns with standard EEG procedures where sterility and consistency are paramount.
Is the AC Cream Conductive Paste dermatologically tested?
Yes, the AC Cream Conductive Paste has undergone dermatological testing to ensure minimal skin irritation. It is also free from parabens, dyes, and fragrances, which helps reduce the likelihood of adverse skin reactions during prolonged or repeated use in EEG procedures.
Can the AC Cream Conductive Paste be reused?
No, the AC Cream Conductive Paste is explicitly intended for single-use applications only. Reusing it could compromise sterility and the integrity of the conductive properties, potentially leading to inaccurate EEG readings or skin irritation. Always follow the manufacturer’s guidelines for optimal performance and safety.
What regulatory approval does the AC Cream Conductive Paste hold?
The AC Cream Conductive Paste holds FDA 510(k) clearance under the product code GYB, classified as Class II with Special Controls. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device and meets the regulatory requirements for electroconductive media used in EEG applications.
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: Pastes and Gel - Spes Medica, PDF AC CREAM - Spes Medica, K212326 FDA 510 (k) - AC Cream - Conductive paste, AC Cream - Conductive paste (K212326) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212326 | Class II | Active |
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Manufacturer
- Manufacturer
- Spes Medica Srl
Sources (1)
- FDA 510(k) K212326 24 fields · synced Oct 1, 2026