FDA product code ODR

Electrosurgical Patient Return Electrode

General, Plastic Surgery·Class 2·21 CFR 878.4400
US regulatory classifications
US Product Code (FDA)
ODR
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4400
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

Ground pad used to finish circuit during electrosurgery. A single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.

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About this record

Electrosurgical Patient Return Electrode is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.