Variable Temperature Cautery Device

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

510(k) Number

K843974 ↗

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 types of surgical procedures is this cautery device designed to assist with, and how does its variable temperature feature help during those procedures?

  This device is designed for general and plastic surgery procedures where precise tissue coagulation and cutting are required. The variable temperature feature—ranging from about 100°F to 2200°F—allows clinicians to adjust the heat output, enabling finer control over thermal effects. This adaptability helps minimize collateral damage to surrounding tissues, reduces charring, and improves precision during delicate operations like skin grafts or nerve repairs.

• Is this cautery device meant for repeated use in the same patient or a single procedure, and what does that mean for maintenance or replacement?

  The device is explicitly designed for single-use only, meaning it should not be reused on the same patient or for multiple procedures. This design eliminates the need for cleaning, sterilization, or maintenance between uses, reducing the risk of cross-contamination and ensuring consistent performance. After one use, the device should be discarded in accordance with standard surgical waste protocols.

• How is the device supplied, and do I need to perform any special preparation before using it in surgery?

  The device is supplied sterile and ready for immediate use. No additional preparation—such as sterilization or cleaning—is required beyond standard surgical instrument handling. Simply remove it from its packaging under sterile conditions and integrate it into the procedure as needed.

• What should I consider when storing this device before its first use, and how long can it remain unused?

  The device should be stored in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is single-use and sterile, there is no expiration date tied to storage duration, but it is critical to ensure the packaging remains intact and uncompromised. Always verify the sterility barrier is undamaged before use.

• How do I know this device is compliant with U.S. regulatory requirements, and what does the FDA clearance mean for its use?

  This device holds an FDA 510(k) clearance (K843974), which means it has been determined to be substantially equivalent to a legally marketed predicate device (a previously approved cautery tool) and meets applicable safety and performance standards. The clearance confirms it complies with U.S. regulations for surgical cautery instruments, ensuring it can be legally marketed and used in clinical settings as described. Always refer to the device’s labeling and the FDA’s summary of safety and effectiveness for full details.