Solo-Dex, Inc

Solo-Dex, Inc specializes in devices for continuous peripheral nerve block procedures. Their primary product category is peripheral nerve-block sharp needles, including catheter-and-needle kits and standalone nerve block sets. These devices are designed for regional anesthesia, enabling long-term pain management by maintaining nerve blockade over extended periods. Examples include the *Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit* and the *Fascile Continuous Peripheral Nerve Block Set*.

Solo-Dex, Inc is based in the United States, which means its devices are subject to FDA regulatory oversight. As a U.S.-based manufacturer, their products must comply with FDA requirements, including premarket notification (510(k)) submissions for Class II devices and adherence to the Unique Device Identification (UDI) system. This ensures their devices meet U.S. medical device standards before entering the market.

Solo-Dex, Inc’s devices are listed in the FDA’s regulatory databases, specifically under 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. These registries confirm that the devices have undergone the necessary regulatory processes to demonstrate compliance with U.S. medical device requirements before commercial distribution.

Solo-Dex, Inc’s devices fall under FDA Class II classification, which is the second-highest risk category for medical devices. This classification requires manufacturers to submit a 510(k) premarket notification to demonstrate that their device is substantially equivalent to a legally marketed predicate device. Class II devices also require compliance with special controls and, in this case, adherence to the UDI system, ensuring traceability and regulatory tracking.