BLACK & BLACK SURGICAL, INC.

Black & Black Surgical, Inc. specializes in reusable and single-use surgical instruments primarily used in plastic and general surgery. Their product lineup includes liposuction cannulas (both reusable and disposable), hand-held surgical retractors, monopolar electrosurgical electrodes, general-purpose surgical scissors, soft-tissue manipulation forceps, fibreoptic light cables, and plastic surgery files/rasps. These tools are designed for procedures requiring precision and sterility in operating environments.

Black & Black Surgical, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies their instruments as either Class I or Class II, depending on the risk associated with the device’s use and intended purpose. This classification determines the level of scrutiny and regulatory requirements the devices must meet.

Black & Black Surgical, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identify medical devices throughout their distribution and helps ensure traceability, transparency, and compliance with regulatory requirements. This listing is essential for tracking devices in clinical settings and maintaining regulatory records.

Black & Black Surgical, Inc.’s devices are classified under FDA’s Class I and Class II categories. Class I devices are generally considered low-risk and may require only general controls like good manufacturing practices. Class II devices pose a higher risk and require additional controls, such as special labeling or performance standards, to ensure safety and effectiveness. The classification determines the regulatory pathway and oversight required for each device, influencing how they are reviewed, approved, and monitored.