Axcess Surgical Innovations LLC.

Axcess Surgical Innovations LLC specializes in reusable hand-held surgical retractors and manually-adjusted surgical instrument assist arm systems. These devices are designed to enhance surgical exposure and assist in positioning instruments during procedures. Their product line includes rigid arm retractors like the Atlas™ series, which offer adjustable lengths and column configurations for tailored use in operating rooms.

Axcess Surgical Innovations LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, particularly in markets like the EU and the US, where its products are listed in databases such as eudamed and the FDA’s UDI system.

Axcess Surgical Innovations LLC’s devices are listed in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices, helping healthcare providers and regulators verify product details, compliance, and availability in their respective markets.

Axcess Surgical Innovations LLC’s devices are classified as Class I under regulatory frameworks. This classification typically applies to low-risk medical devices, such as surgical retractors and assist arms, which are considered to pose minimal risk to patients when used as intended. Classification determines the regulatory pathway for authorization, with Class I devices often requiring less stringent scrutiny than higher-risk categories.