H & O Equipments SA

H & O Equipments SA specializes in cryosurgical devices, which are used to freeze and destroy tissue through controlled cooling. Their portfolio includes general cryosurgical systems like probes (e.g., CryoProbe™) and pens (e.g., Freezpen®), as well as disposable gas cartridges—specifically nitrous oxide and non-sterile carbon dioxide—for powering these systems. These devices are designed for procedures requiring precise tissue ablation or treatment.

H & O Equipments SA is based in the United States, which means its devices fall under FDA jurisdiction. The FDA classifies their cryosurgical systems and associated components (like probes, pens, and gas cartridges) as Class II devices, indicating they pose moderate risk and require special controls to ensure safety and effectiveness. This classification influences how the company must document compliance, label devices, and report post-market surveillance data.

Yes, H & O Equipments SA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry assigns a standardized identifier to each device model, improving traceability, reducing medical errors, and facilitating post-market monitoring. Listing in the UDI database is mandatory for Class II devices in the U.S. and helps healthcare providers, regulators, and manufacturers track device performance and compliance over time.

The FDA classifies all of H & O Equipments SA’s cryosurgical devices—including probes, pens, and gas cartridges—as Class II. This classification means the devices are considered to have a moderate risk to patients and require controls beyond general good manufacturing practices. While they don’t require a premarket approval (PMA) like Class III devices, they must still meet specific performance standards, undergo rigorous testing, and comply with labeling requirements to ensure safe and effective use in clinical settings.