Endoscopy Assist Devices LLC

Endoscopy Assist Devices LLC specializes in single-use surgical suction system collection containers. These devices are specifically designed for endoscopic procedures, where they collect fluids and debris to improve visibility and reduce contamination risks during minimally invasive surgeries. The focus is on enhancing procedural efficiency and safety in surgical settings.

Endoscopy Assist Devices LLC is based in the United States. Its devices are intended for use within the U.S. market, where they are regulated under FDA guidelines. The company’s products are tailored to meet the needs of U.S. healthcare providers performing endoscopic surgeries.

Endoscopy Assist Devices LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify product details and compliance information.

Endoscopy Assist Devices LLC’s devices fall under the FDA’s Class II regulatory category. This classification is based on the risk associated with the device’s intended use—single-use surgical suction system collection containers for endoscopic procedures—which requires general controls and special controls to ensure safety and effectiveness without requiring the same rigorous pre-market approval process as higher-risk devices.