Polyhesive Patient Return Electrode
510(k) K822572
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822572 | Date21 Sep 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Polyhesive Patient Return Electrode is a disposable adhesive electrode designed for use in electrocautery and surgical procedures. It serves as a return electrode, completing the electrical circuit between the active electrode and the patient to ensure safe and effective operation of electrocautery devices. Constructed with a high-moisture conductive adhesive hydrogel, it provides reliable conductivity without the residue associated with traditional gel-based electrodes. This device is classified under the product code GEI in the FDA’s nomenclature system.
This electrode is supplied as a single-use, sterile device intended for attachment to the patient’s skin during surgical procedures. It is intended for use with electrocautery systems and is compatible with MRI environments as it contains no metallic components that could interfere with imaging. The device is packaged in a sterile, peel-open pouch and must be stored in a cool, dry place away from direct sunlight. Authorized for use in the United States under FDA 510(k) clearance (K822572), it adheres to regulatory standards for safety and performance in surgical settings.
Other devices from Valleylab, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Polyhesive Patient Return Electrode used for?
The Polyhesive Patient Return Electrode is designed to complete the electrical circuit during electrocautery procedures by serving as a return electrode. It connects the active electrode to the patient, ensuring safe and effective operation of electrocautery devices. Its high-moisture conductive adhesive hydrogel provides reliable conductivity without leaving residue, making it ideal for surgical settings where precision and cleanliness are critical.
How is the Polyhesive Patient Return Electrode supplied and prepared for use?
The electrode is supplied as a single-use, sterile device in a peel-open pouch. Before use, the pouch should be opened carefully, and the electrode applied directly to the patient’s skin. It is intended for one-time use only, ensuring sterility and reducing the risk of contamination during surgical procedures.
Is the Polyhesive Patient Return Electrode reusable or single-use?
This electrode is explicitly designed for single-use only. Its sterile packaging and adhesive properties are optimized for one-time application to maintain safety and hygiene standards in surgical environments. Reuse is not recommended or supported by the manufacturer.
Can the Polyhesive Patient Return Electrode be used in MRI environments?
Yes, the Polyhesive Patient Return Electrode is MRI-compatible because it contains no metallic components. This makes it suitable for use in MRI environments without interference, ensuring compatibility with imaging procedures where electrocautery may also be required.
How should the Polyhesive Patient Return Electrode be stored?
The electrode should be stored in a cool, dry place away from direct sunlight. Proper storage conditions help preserve its adhesive properties and sterility, ensuring it remains effective when needed for surgical procedures.