CROWN SURGICAL CORPORATION

Crown Surgical Corporation specializes in single-use surgical instruments. Their primary products include dressing/utility forceps for precise tissue handling, general-purpose surgical scissors for cutting sutures or tissue, and suturing needle holders designed to assist with needle manipulation during surgery. These tools are intended for use in various surgical procedures.

Crown Surgical Corporation is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under U.S. medical device regulations, including those governed by the FDA.

Crown Surgical Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each product has a standardized identifier for traceability, compliance tracking, and transparency in the supply chain. The UDI system is a key resource for verifying and monitoring medical devices.

All of Crown Surgical Corporation’s listed devices fall under Class I classification in the FDA’s regulatory framework. This classification applies to low-risk surgical instruments, such as single-use forceps, scissors, and needle holders, which are deemed to pose minimal risk to patients when used as intended. Class I devices typically require general controls but may not need premarket approval.