Estech Cobra Surgical System With Thermashield Accessory

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K110913 ↗

FDA Product Code

OCL

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 the Estech Cobra Surgical System primarily used for, and how does it differ from standard electrosurgical tools?

  The Estech Cobra Surgical System is designed for general and plastic surgery procedures, specifically for cutting, coagulation, and ablation of soft tissues—including cardiac tissue. Unlike standard electrosurgical tools, it incorporates a Thermashield accessory, a single-use silicone pad that provides thermal insulation to minimize damage to surrounding non-target areas, allowing for more precise tissue modification using radiofrequency (RF) energy.

• Is the Thermashield accessory reusable, or is it intended for single-use only? How does this impact surgical workflow?

  The Thermashield accessory is explicitly described as a single-use item, paired with the reusable electrosurgical instrument. This design ensures sterility and reduces cross-contamination risks in sterile surgical environments, requiring clinicians to replace the pad after each procedure rather than reprocessing it.

• What regulatory pathway was followed for FDA clearance of this device, and what does the classification mean for its use?

  The Estech Cobra Surgical System received FDA 510(k) clearance under classification II (K110913), with a decision labeled as *Substantially Equivalent* (SESE). This classification means the device was deemed comparable to a legally marketed predicate device in terms of safety and effectiveness, adhering to regulatory standards outlined in 21 CFR 878.4400 for electrosurgical instruments. The clearance does not imply indications but confirms compliance with performance and safety requirements.

• How is the device supplied, and what considerations should clinicians take for storage or handling?

  The system is supplied as a reusable electrosurgical instrument paired with a single-use Thermashield accessory. Since the instrument is reusable, it must be properly cleaned, sterilized, and stored per manufacturer guidelines to maintain functionality and safety. The Thermashield accessory, being single-use, should be stored in a sterile barrier pouch until use and discarded after a single procedure to prevent contamination.