High Temperature Cautery 5 Loop

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

510(k) Number

K945759 ↗

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 Aaron Medical Industries →

• What is the High Temperature Cautery 5 Loop used for in surgery?

  The High Temperature Cautery 5 Loop is specifically designed for tissue coagulation and cutting during surgical procedures. Its high-temperature capability (up to 2200°F/1204°C) provides precise control over bleeding and tissue manipulation, particularly in general and plastic surgery. The loop-shaped tip allows for targeted application, minimizing damage to surrounding tissues while ensuring effective hemostasis.

• How is the High Temperature Cautery 5 Loop supplied, and what is the packaging reference?

  The device is supplied as a single-use, disposable item. It comes packaged in boxes containing 10 units, with the reference number AA09. This packaging ensures sterility and ease of use in controlled surgical environments.

• Is this cautery loop compatible with all electrosurgical generators?

  The 5-inch shaft with high-temperature loop tip is optimized for use with Aaron Medical Industries’ electrosurgical generators. While designed for compatibility with their systems, users should verify specific generator compatibility to ensure consistent performance and safety during procedures.

• How should the High Temperature Cautery 5 Loop be stored to maintain sterility?

  To preserve sterility, the device must be stored in a clean, dry environment away from direct sunlight or moisture. The packaging should remain intact until immediate preoperative use. Avoid exposure to extreme temperatures or contaminants that could compromise its integrity.

• Can this cautery loop be reused, or is it intended for single-use only?

  The High Temperature Cautery 5 Loop is intended for single-use only. Reusing this device poses risks to patient safety, including infection and reduced performance due to thermal degradation. Adherence to single-use guidelines ensures reliable cautery and maintains regulatory compliance.