STRYKER MEDTECH K.K.

Stryker MedTech K.K. specializes in reusable ultrasonic surgical systems, specifically soft-tissue ultrasonic surgical system handpieces and generators. These devices, such as the Hyper LT and Sonopet, are engineered for precise cutting and coagulation during surgical procedures by leveraging ultrasonic energy to manipulate tissue efficiently.

Stryker MedTech K.K. is based in the United States. The company operates under regulatory frameworks applicable to its listed medical devices, ensuring compliance with relevant standards for ultrasonic surgical instruments.

Stryker MedTech K.K.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry includes Class U devices, which are categorized under the FDA’s classification system for medical instruments.

Stryker MedTech K.K.’s ultrasonic surgical devices, such as handpieces and generators, fall under Class U classification in the FDA’s regulatory framework. This classification applies to devices that pose minimal risk and are typically subject to listing requirements rather than pre-market approval.