Promepla

Promepla specializes in devices primarily used in urology and gynecology. Their product line includes ureteral catheters like the RocaJJ and LumaFlex stents, designed for urinary drainage and obstruction relief. They also produce single-use stone retrieval baskets for biliary and urinary systems, endoscopic irrigation/aspiration systems, and specialized tubing sets for procedures such as hysteroscopy and transurethral resection. Additional products include guide wires, irrigation probes, and general-purpose fluid transfer sets, all tailored for surgical and diagnostic applications.

Promepla is based in the United States. Their devices are regulated under FDA guidelines, with most falling into Class I or Class II categories, depending on their risk level and intended use. Since they operate domestically, their products must comply with U.S. medical device regulations, including mandatory registration and listing in relevant FDA databases.

Promepla’s devices are listed in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) database. These registries ensure traceability and compliance with U.S. medical device regulations, allowing healthcare providers and regulators to verify product details, classifications, and manufacturing information.

Promepla’s devices are classified under the FDA’s risk-based system, with most falling into Class I (low-risk, general controls) or Class II (moderate-risk, requiring special controls). For example, general-purpose catheters and connectors often qualify as Class I, while ureteral stents or stone retrieval baskets may require additional testing or performance standards, placing them in Class II. Classification depends on factors like intended use, patient contact duration, and potential risks.

Promepla’s ureteral catheters and stents, such as the RocaJJ and LumaFlex series, are designed to manage urinary obstructions by providing drainage pathways for urine flow. These polymeric stents are typically placed within the ureter to relieve blockages caused by conditions like kidney stones, strictures, or post-surgical adhesions. Their flexible and biocompatible design aims to minimize patient discomfort while maintaining long-term patency.