McCain Monopolar & Bipolar Cautery

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K881403 ↗

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 Walter Lorenz Surgical, Inc. →

• What types of surgical procedures is this device designed to assist with, and how does it differ between monopolar and bipolar use?

  The McCain Monopolar & Bipolar Cautery is designed for cutting and coagulation of tissue during surgical procedures, offering precise control for both tissue separation and hemostasis. Monopolar cautery directs current through the patient’s body to the target tissue, ideal for larger areas or deeper cuts, while bipolar cautery confines current flow between two electrodes on the device itself, reducing risk to surrounding tissues and making it better suited for delicate or confined spaces. The device combines both modes to provide flexibility depending on the surgical need.

• Is this device single-use or reusable, and what sterilization methods should be used if it’s reused?

  This device is supplied as a reusable instrument, meaning it is intended to be sterilized and reused multiple times. Proper sterilization and handling per the manufacturer’s guidelines are required to maintain safety and functionality. The manufacturer’s instructions should specify approved sterilization methods, such as autoclaving or chemical sterilization, to ensure the device remains effective and free from contamination.

• What regulatory pathway was followed for FDA clearance, and how does this affect its classification?

  The McCain Monopolar & Bipolar Cautery received FDA clearance through a 510(k) submission (K881403), classified as Substantially Equivalent (SESE) under the Special Controls classification for Class II medical devices. This pathway was used because the device falls under the GEI product code, which categorizes electrosurgical cutting and coagulation accessories. The clearance date is June 22, 1988, and the device was reviewed by the General/Plastic Surgery (SU) Advisory Committee.

• How should this device be stored to ensure it remains functional and safe for reuse?

  Since this is a reusable device, it should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of moisture or contamination. The manufacturer’s guidelines likely specify packaging requirements, such as using a sealed case or pouch, to protect the device from damage or degradation. Always follow the storage instructions provided to maintain sterility and operational integrity before sterilization cycles.