Disposable Distal End Tape Hood
Shanghai SeeGen Photoelectric Technology Co., Ltd.The Disposable Distal End Tape Hood is a single-use accessory that attaches to the tip of compatible colonoscopes to help maintain a clear field of view during endoscopic procedures like mucosal resection. It keeps a certain distance between the scope lens and the mucosa, improving visibility for clinicians.
Intended Use
This product is intended to be used in combination with compatible colonoscopes to maintain the field of view during endoscopic procedures such as mucosal resection. This product needs to be cut and connected to the endoscope tip of 9mm to 14mm, and medical tape needs to be prepared in advance to fix it into a cylindrical shape.
Technology
The Disposable Distal End Tape Hood is a strip-shaped, disposable accessory designed to be wrapped around the tip of the endoscope (diameter 9-14mm). It assists in endoscopic visualization by pushing away mucosa and maintaining a distance between the lens and tissue to keep the field of view clear.
Performance
Performance testing included comparison to a predicate device in terms of dimensions, functionality, and safety to demonstrate no new safety or effectiveness concerns. Mechanical and reliability tests, biocompatibility per ISO 10993, sterilization validation, and EO residual testing were performed. No clinical study was conducted.
Predicate Devices
No predicate devices specified
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