Amcath Coagulation Probe HFG

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

Full name

Amcath Coagulation Probe

510(k) Number

K902555 ↗

FDA Product Code

HFG

Device Class

Class II

Regulation

21 CFR Part 884.4160

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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See all devices from Intl. Medical, Inc. →

• What surgical specialties is the Amcath Coagulation Probe primarily used in, and why is it designed for laparoscopic procedures?

  The Amcath Coagulation Probe is designed for use in obstetrics and gynecology settings, as indicated by its advisory committee classification and medical specialty description. It is specifically tailored for laparoscopic procedures because it delivers controlled electrical energy to coagulate tissue and seal blood vessels with precision, reducing bleeding during minimally invasive surgeries. This makes it ideal for delicate procedures where traditional open surgery techniques may not be feasible.

• Is the Amcath Coagulation Probe intended for single-use or reusable applications, and what does this mean for maintenance?

  The Amcath Coagulation Probe is reusable, as explicitly stated in the device description. This means it is designed for repeated use in clinical settings, requiring proper cleaning, sterilization, and maintenance between procedures to ensure safety and functionality. Reusability also implies that facilities must follow established protocols for instrument reprocessing to comply with regulatory standards.

• How is the regulatory status of this device determined, and what does the product code (HFG) signify in its classification?

  The Amcath Coagulation Probe holds a FDA 510(k) clearance (K902555), classified under product code HFG for administrative tracking. The clearance was granted under Substantially Equivalent (SESE) standards, meaning it was determined to have the same intended purpose and technological characteristics as a legally marketed device. The product code (HFG) is used by regulatory bodies to categorize and track devices like this one, which fall under FDA regulation 884.4160 and are classified as Class II devices.

• What types of tissue coagulation does this device support, and how does its unipolar design contribute to surgical precision?

  The Amcath Coagulation Probe is a laparoscopic, unipolar coagulator, meaning it delivers electrical energy to coagulate tissue and seal blood vessels during minimally invasive procedures. Its unipolar design allows for precise control of energy application, reducing collateral damage to surrounding tissues while effectively stopping bleeding. This is particularly useful in obstetrics and gynecology, where delicate structures require careful handling.