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FDA Endoscope Clearance Data Analysis 2022–2026
By searching keywords such as “endo,” “scope,” and “scopy” in the 510(k) database and conducting manual screening, a total of 305 endoscope clearance records from the past five years (2022 to April 2026) were identified. Objectively, there may still be incomplete statistics, and the following content is summarized solely based on the above data.
Note: In FDA endoscope registrations, imaging systems are usually registered as a complete system including both the processor and the scope, which differs from China’s NMPA registration approach where processors and scopes are registered separately. Although the data in this article has been reviewed against the Summary documents as thoroughly as possible to ensure accuracy, 100% accuracy cannot be guaranteed.
I. Overall Trend
The trend of FDA endoscope registrations has continued to rise year by year, with a cumulative total of 305 clearances granted.
Among them, Chinese companies obtained 127 clearances (including Mainland China, Hong Kong, Macau, and Taiwan), far exceeding expectations.
The growth trend of endoscope registrations in the United States is generally consistent with the Chinese market, showing steady year-by-year growth; however, the total number remains significantly lower than the current scale of the Chinese domestic market.
The trends for disposable endoscopes and reusable endoscopes in the United States from 2022 to April 2026 are shown in the chart, demonstrating an overall upward trajectory, which is generally consistent with the trend observed in the Chinese market.
II. Single-use vs. Reusable Endoscopes
- In the FDA system over the past five years, single-use endoscopes accounted for 56% of registrations, surpassing reusable ones.
III. U.S. Endoscope Registration Popularity Ranking (FDA, Past 5 Years)
Here is the translated ranking of endoscope registration trends in the U.S. market:
- Gastrointestinal (GI) Endoscopes – 82
- Bronchoscopes – 43
- Ureteroscopes – 42
- Cystoscopes – 36
- Laparoscopes – 20
IV. Popularity by Clinical Department
High-Trend Registered Departments (U.S.): Gastroenterology, Urology, Pulmonology, and General Surgery.
V. Reusable vs. Disposable by Department (USA)
Top 3 Departments for Reusable Endoscope Popularity:
- Gastroenterology (GI)
- General Surgery (Laparoscopy, Choledochoscopy)
- Urology
Top 3 Departments for Disposable Endoscope Popularity:
- Urology
- Pulmonology / Respiratory Medicine
- Gastroenterology (GI)
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