Ark Surgical, Ltd.

Ark Surgical, Ltd. specializes in tissue extraction bags, specifically designed for laparoscopic surgeries. These devices, such as the LapBox Power and LapBox Tissue Containment Removal System, are intended to safely contain and remove excised tissue during minimally invasive procedures. The focus is on ensuring tissue integrity and procedural efficiency in surgical settings.

Ark Surgical, Ltd. is headquartered in the United States. The company’s location in the US aligns with its regulatory compliance requirements, particularly for devices listed under FDA programs.

Ark Surgical, Ltd.’s devices are listed in the FDA’s 510(k) premarket notification program and the FDA’s Unique Device Identification (UDI) system. These registries ensure traceability and compliance tracking for Class II medical devices, which are subject to stricter controls due to their moderate risk.

Ark Surgical, Ltd.’s tissue extraction bags fall under Class II medical device classification. This classification is assigned based on the risk level of the device—Class II devices require special controls in addition to general controls to ensure their safety and effectiveness, as they pose a higher risk than Class I but lower than Class III devices.