PHENOX LIMITED

Phenox Limited specializes in vascular devices used primarily for thrombectomy and peripheral vascular interventions. Their portfolio includes wire-net thrombectomy devices designed to remove blood clots from vessels, available in various sizes to match different anatomical needs. They also produce vascular microcatheters, which are flexible tubes used to navigate blood vessels, and steerable hydrophilic guidewires, which assist in guiding catheters to precise locations within the vascular system.

Phenox Limited is based in the United States. Their devices fall under FDA Class II classification, which typically includes moderate-risk medical products requiring performance standards or special controls to ensure safety and effectiveness. This classification reflects the regulatory oversight required for their thrombectomy and vascular devices.

Phenox Limited’s devices are included in the FDA’s 510(k) premarket notification registry, which tracks products seeking clearance through a 510(k) submission to demonstrate substantial equivalence to a predicate device. Additionally, their devices appear in the FDA’s Unique Device Identification (UDI) system, which standardizes identification for medical products to improve tracking and reduce errors.

Phenox Limited’s thrombectomy devices, including wire-net retrieval systems and related accessories, are classified as FDA Class II devices. This classification is assigned based on the risk level of the product—Class II devices require special controls beyond general controls to ensure their safety and performance, such as performance standards or post-market surveillance, without requiring the stringent pre-market approval process of Class III devices.