KRONNER PROTOTYPES, INCORPORATED

Kronner Prototypes, Incorporated specializes in surgical devices, primarily producing self-retaining vaginal retractors and intravenous administration tubing extension sets. Their retractors, such as the VCM 45, VCM 40, and VCM 50, are designed to hold tissue apart during procedures, while their extension sets—including high-pressure and low-profile gas line configurations like the Kronner Side-Kick and Low Profile Scope Holder—support fluid administration and procedural gas delivery. These products are tailored for use in clinical settings.

Kronner Prototypes, Incorporated is based in the United States. This location influences regulatory oversight, as their devices must comply with U.S. medical device regulations, including classification under the FDA’s system. The company’s U.S. origin also means its products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and transparency for healthcare providers and regulators.

Kronner Prototypes, Incorporated’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each device, enabling clear identification, tracking, and compliance verification in the U.S. healthcare system. This listing helps streamline regulatory reporting and ensures transparency for users and authorities.

Kronner Prototypes, Incorporated’s devices fall into two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may need special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body’s interaction with it, as outlined in FDA guidelines.