Neomed Non Gel-R Total Adhesive Conduct. Electrode

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K863360 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Richards Medical Co., Inc. →

• What is the NEOMED Non Gel-R Total Adhesive Conductive Electrode used for?

  The NEOMED Non Gel-R Total Adhesive Conductive Electrode is an electrosurgical accessory designed specifically for use in cutting and coagulation procedures. It provides a fully adhesive conductive surface for electrosurgical applications in medical settings.

• Is the NEOMED Non Gel-R Total Adhesive Conductive Electrode reusable or single-use?

  The NEOMED Non Gel-R Total Adhesive Conductive Electrode is supplied as a single-use item and is not intended for reuse. It should be discarded after a single procedure to ensure patient safety and maintain device performance.

• What are the storage requirements for the NEOMED Non Gel-R Total Adhesive Conductive Electrode?

  The NEOMED Non Gel-R Total Adhesive Conductive Electrode should be stored in a dry environment to maintain its adhesive properties and functionality. It is not MRI safe and should not be used in MRI environments.

• What is the regulatory status of the NEOMED Non Gel-R Total Adhesive Conductive Electrode?

  The NEOMED Non Gel-R Total Adhesive Conductive Electrode is regulated under FDA 510(k) clearance with product code GEI. It was cleared on September 12, 1986, and is classified as substantially equivalent to predicate devices.