Urogen Pharma, Ltd.

Urogen Pharma, Ltd. specializes in several categories of medical devices, including pharmaceutical cooling blocks for controlled temperature applications, single-use urethral drainage catheters for urinary management, and syringe dispensing mechanisms like screw-press levers for precise fluid administration. Their portfolio also includes non-medicated urological surgical procedure kits and ureteral catheters, such as a 7 Fr. variant, as well as kits designed for ureteral catheter administration. These devices are tailored for urological and procedural needs.

Urogen Pharma, Ltd. is based in the United States, which means its devices fall under U.S. regulatory frameworks, specifically those governed by the FDA. Since the company operates within the U.S., its products are subject to FDA classifications, including Class I and Class II, and are tracked through registries like the 510(k) and UDI systems. This ensures compliance with U.S. medical device regulations.

Urogen Pharma, Ltd.'s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) process is used for demonstrating substantial equivalence to existing devices, while the UDI system ensures traceability and identification of medical devices throughout their lifecycle. These registries help track compliance and authorization status for individual products.

Urogen Pharma, Ltd.'s devices are classified under FDA categories, primarily as Class I or Class II. Class I devices generally pose the lowest risk and are subject to general controls, while Class II devices require additional controls due to moderate risk. The classification depends on the device’s intended use and potential risk to patients, as outlined in FDA guidelines. Each device’s classification determines the regulatory pathway it follows for authorization.

Urogen Pharma, Ltd. offers ureteral catheters, including a 7 Fr. variant, and non-medicated urological surgical procedure kits designed for single-use applications. These products are tailored for precision and safety in urological procedures, with the ureteral catheters specifically engineered for controlled placement within the urinary tract. The kits are intended to streamline surgical workflows while adhering to regulatory standards for single-use medical devices, ensuring minimal risk of contamination or cross-infection.