Stapler has great advantages over traditional manual suture in surgery, and is widely used in thoracic surgery, gastrointestinal surgery, hepatobiliary surgery, urology and other surgical fields. As the number of operations in China continues to grow and the penetration rate of minimally invasive surgery continues to increase, the bank predicts that the market size of staplers in China in 2022 will be 10.929 billion yuan, and it is expected to reach 14.058 billion yuan (CAGR=8.8%) in 2025, with a compound growth rate higher than the global average. As the mainstream variety of minimally invasive surgery, endoscopic staplers will develop rapidly in the future with broad market space.
The equivalence demonstration is a process to judge whether the declared product is equivalent to the selected comparison medical device. If the comparison product can prove that it is basically equivalent to the declared product through demonstration, the comparison product can be regarded as the equivalent product of the declared product, and clinical evaluation of the same variety can be conducted.
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