Lapovations, LLC

Lapovations, LLC specializes in laparoscopic access suction domes, such as the AbGrab device. These devices are designed for use in minimally invasive surgeries, specifically to assist with controlled suction and access during procedures, helping surgeons manage tissue and fluids more effectively.

Lapovations, LLC is based in the United States. Since its devices are classified as Class I medical devices, they are subject to the regulatory requirements set by the U.S. Food and Drug Administration (FDA), including compliance with UDI (Unique Device Identifier) listing.

Yes, Lapovations, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices in the U.S., allowing healthcare providers, regulators, and other stakeholders to verify device details, such as manufacturer information and classification, for compliance and safety purposes.

Lapovations, LLC’s devices, including the AbGrab laparoscopic access suction dome, are classified as Class I medical devices. This classification is determined by the FDA based on the risk associated with the device’s intended use. Class I devices generally pose the lowest risk and typically require only general controls to ensure safety and effectiveness.