Hemostatix Thermal Scalpel System – #12 Blade

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

510(k) Number

K002021 ↗

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 the Hemostatix Thermal Scalpel System – #12 Blade primarily used for?

  The Hemostatix Thermal Scalpel System – #12 Blade is designed for use in general and plastic surgery procedures. Its dual functionality as a haemostatic knife allows for precise tissue cutting while simultaneously coagulating to minimise bleeding, reducing the need for additional haemostatic agents during these surgeries.

• How is the Hemostatix Thermal Scalpel System – #12 Blade supplied, and is it reusable?

  The Hemostatix Thermal Scalpel System – #12 Blade is supplied as a single-use, sterile disposable blade. It is not intended for reuse, and proper handling and storage per manufacturer guidelines are required to maintain its sterility and performance.

• Does this device require a specific electrosurgical generator for use, and how is it integrated?

  Yes, the Hemostatix Thermal Scalpel System – #12 Blade is designed for integration with an electrosurgical generator. It combines scalpel functionality with thermal energy, so it must be used in conjunction with a compatible generator to achieve coagulation during tissue cutting.

• Are there any special storage instructions for the Hemostatix Thermal Scalpel System – #12 Blade?

  While specific storage instructions are not detailed in the provided data, the blade is a sterile, single-use disposable device. It should be stored according to the manufacturer’s guidelines to preserve sterility and performance, as improper handling could compromise its functionality.

• Is this device safe for use in an MRI environment, or are there any MRI-related warnings?

  The provided data does not specify MRI safety information for the Hemostatix Thermal Scalpel System – #12 Blade. If MRI compatibility is required, users should consult the manufacturer’s instructions or documentation for guidance.