3m Scotchplate Ii Dispersive Electrode
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K833364 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 Scotchplate II Dispersive Electrode is a medical device classified under Electrosurgical, Cutting & Coagulation & Accessories (FDA Product Code: GEI). It functions as a dispersive electrode, designed to safely distribute electrical current during electrosurgical procedures, reducing the risk of tissue damage by spreading the current across a larger area of the patient’s body.
This device is intended for single-use in controlled clinical settings, such as operating rooms or procedural suites, where electrosurgical procedures are performed. Supplied sterile and packaged individually, it adheres to FDA clearance (510(k) K833364) under Regulation 878.4400, with a classification as Class II. No additional sterility or reuse instructions are specified beyond standard electrosurgical safety protocols.
Frequently asked questions
What is the 3M Scotchplate II Dispersive Electrode used for?
The 3M Scotchplate II Dispersive Electrode is designed to safely distribute electrical current during electrosurgical procedures. By spreading the current across a larger area of the patient’s body, it helps minimize localized tissue damage, ensuring safer and more effective operations in controlled clinical settings like operating rooms or procedural suites.
Is the 3M Scotchplate II Dispersive Electrode sterile and single-use?
Yes, the 3M Scotchplate II Dispersive Electrode is supplied sterile and intended for single-use only. This ensures hygiene and safety in clinical environments where sterility is critical, preventing cross-contamination and maintaining procedural integrity.
How is the 3M Scotchplate II Dispersive Electrode packaged, and what are its regulatory details?
The device is packaged individually and supplied sterile, adhering to FDA clearance under the 510(k) submission K833364. It falls under the Electrosurgical, Cutting & Coagulation & Accessories category (FDA Product Code: GEI) and is classified as Class II. No additional reuse or sterility instructions are required beyond standard electrosurgical safety protocols.
Can this electrode be reused, and if not, why?
No, the 3M Scotchplate II Dispersive Electrode is explicitly designed for single-use only. Reuse is not recommended due to potential contamination risks, degradation of sterility, and compromised performance over repeated applications, which could affect patient safety during electrosurgical procedures.
What safety measures should be followed when using this dispersive electrode?
While the device itself is sterile and single-use, standard electrosurgical safety protocols should always be followed, including proper patient grounding, ensuring the electrode adheres securely to a large, non-hairy area of the patient’s skin, and avoiding direct contact with sensitive tissues or metal implants. These measures help prevent burns, ensure even current distribution, and maintain procedural safety.
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: 3M SCOTCHPLATE II DISPERSIVE ELECTRODE - Innolitics, 3M SCOTCHPLATE II DISPERSIVE ELECTRODE 510(k) K833364 - fda.report, 3m Scotchplate Ii Dispersive Electrode - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K833364 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K833364 24 fields · synced Oct 1, 2026