Bouie Electrosurgical Tip Cleaner

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

510(k) Number

K802827 ↗

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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• What is the Bouie Electrosurgical Tip Cleaner used for?

  The Bouie Electrosurgical Tip Cleaner is designed to remove material buildup from electrosurgical instruments, including monopolar and bipolar probes, pencil tips, and blades. This ensures proper functionality and safety during surgical procedures by maintaining the efficiency of cautery tools, which is critical for precise tissue control and reducing the risk of equipment-related complications.

• How is the Bouie Electrosurgical Tip Cleaner supplied and prepared for use?

  The device is supplied as a sterile, single-use item in a package ready for immediate clinical use. No additional preparation is required beyond removing the packaging under sterile conditions. The adhesive backing allows for secure attachment to the instrument, ensuring effective cleaning during surgery.

• Is the cleaner reusable, or is it intended for single-use only?

  The Bouie Electrosurgical Tip Cleaner is explicitly designed for single-use only. Reusing it could compromise sterility, reduce cleaning effectiveness, and potentially introduce contamination or damage to the electrosurgical instrument, which could affect surgical outcomes.

• Can the cleaner be used with all types of electrosurgical systems?

  The cleaner is engineered to be compatible with standard electrosurgical systems commonly used in surgical settings. However, compatibility should be confirmed with the specific system in use, particularly for bipolar and monopolar probes, to ensure optimal performance and safety during procedures.

• How should the Bouie Electrosurgical Tip Cleaner be stored to maintain sterility?

  Storage should follow the manufacturer’s guidelines to preserve sterility and functionality. Typically, this involves keeping the sealed, sterile packaging intact until use and storing it in a clean, dry environment away from direct sunlight or extreme temperatures. Avoiding moisture exposure and physical damage to the packaging is essential to maintain sterility.