Medical Device Manufacturer · CN , Xiamen

Cathegenix (Xiamen) Co., Ltd.

2 submissions · 1 cleared · Since 2025
2
Total
1
Cleared
0
Denied

Cathegenix (Xiamen) Co., Ltd. — FDA 510(k) Submissions

Cathegenix (Xiamen) Co., Ltd. has submitted 2 FDA 510(k) premarket notifications since 2025, of which 1 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Endoscopic Access Overtube, Gastroenterology-urology, Stent, Ureteral . Use the specialty filter in the sidebar to narrow results.

2 devices
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All2 Gastroenterology & Urology 2