(163 days)
The Trokemed GmbH Resectoscope & accessories are indicated for the resection of prostate tissue. The Trokamed GmbH Monopolar Electrodes are intended for use in minimal invasive techniques where unipolar electrosurgical cutting and coagulation are normally used. The Trokamed GmbH Bipolar Electrodes are intended for use in minimal invasive techniques where bipolar electrosurgical cutting and coagulation are normally used.
The instruments are reusable; they are intended to be cleaned sterilized and reused.
electrosurgical instruments and accessories
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) Summary for Trokamed GmbH's electrosurgical instruments and accessories, which focuses on device description, classification, intended use, substantial equivalence to predicate devices, biocompatibility, and sterilization by the user. It also includes an FDA letter acknowledging the substantial equivalence determination and indicating the device can be marketed.
Therefore, I cannot fulfill your request for the detailed table and information regarding acceptance criteria and studies as it is not present in the provided text.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.