K.T.SURGICO

K.T.Surgico specializes in single-use surgical instruments. Their primary products include general-purpose surgical scissors, soft-tissue manipulation forceps (both tweezers-like and scissors-like designs), and direct-view otoscopes. These devices are engineered for one-time clinical use in surgical and diagnostic settings, ensuring sterility and reducing cross-contamination risks.

K.T.Surgico is based in the United States. Since the company operates within the US, its devices are subject to FDA regulations. All of their listed products fall under Class I classification, which typically requires less stringent premarket review compared to higher-risk devices, as they pose minimal potential harm when used as intended.

Yes, K.T.Surgico’s devices are registered in the FDA’s Unique Device Identification (UDI) database. This listing is important because the UDI system standardizes identification for medical devices, improving traceability, safety monitoring, and regulatory compliance. It helps healthcare providers, hospitals, and regulators track devices throughout their lifecycle, from manufacturing to post-market surveillance.

K.T.Surgico’s devices are classified as Class I under US regulations. This classification is assigned to low-risk devices that are generally considered safe and effective when used as intended. Class I devices typically require only general controls (like good manufacturing practices) and do not usually undergo a formal premarket review unless they are new or modified. This classification reflects the minimal risk associated with their design and intended use.