VESIFLO INC

Vesiflo Inc specializes in intraurethral valve and pump systems, primarily focused on urinary retention management. Their core product is the inFlow Device, a valve/pump designed for controlled urine flow. The company also produces complementary tools like the inFlow Sizing Device, Activator Kit, Magnetic Shield, Medical Charger, and Base Station, all of which support the functionality, maintenance, and safe use of the primary device.

Vesiflo Inc is headquartered in the United States. The company’s devices fall under FDA Class II classification, which indicates moderate risk and requires compliance with specific regulatory controls. These devices are authorized through 510(k) clearances (a premarket submission process) and are listed in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and regulatory tracking.

Vesiflo Inc’s devices are registered in the FDA’s 510(k) database (for premarket clearance records) and the FDA’s Unique Device Identifier (UDI) system, which catalogs authorized medical devices with standardized identification codes. These registries help ensure transparency and compliance with U.S. medical device regulations.

Vesiflo Inc’s devices are classified as FDA Class II, meaning they pose a moderate risk to patients and require special controls beyond general good manufacturing practices. This classification is determined by the FDA based on factors like the device’s intended use, potential risks, and benefits, ensuring that appropriate regulatory oversight is applied to maintain safety and effectiveness.