[Intended use]

To be used with endoscopes, electrosurgical units to cut tissue and coagulate or to perform hemostasis using high-frequency current and flushing devices for submucosal injection in the digestive tract.

[Indications for use]

1. gastrointestinal mucosal and submucosal tumors

2. Zenker’s diverticulum

[Intended patient population]

Medical condition of patients are patients with gastrointestinal mucosal and submucosal tumors and patients with Zenker’s diverticulum. It is intended for use in adults and children who is considered suitable for the endoscopic procedure.

[Contraindications]

1. Patients with contraindications to digestive endoscopy.

2. Patients with bleeding tendency, prolonged bleeding and coagulation time, thrombocytopenia, or prolonged prothrombin time that cannot be corrected after treatment.

3. Other conditions as determined by specialists based on patients' actual conditions.

[Potential Complications]

Potential complications related to the procedure: bleeding, perforation, fever, stenosis, infection and subcutaneous emphysema.

[Intended Users]

The users are qualified physician with adequate training and knowledge of these procedures, i.e., an operator with experience, or an operator working under the supervision of someone with experience (An expert who understands thoroughly functions and characteristics of the device sufficiently and is familiar with endoscopic treatment procedure).