Medical Device Manufacturer · CN , Shanghai

Alton (Shanghai) Medical Instruments Co., Ltd.

6 submissions · 6 cleared · Since 2023
6
Total
6
Cleared
0
Denied

Alton (Shanghai) Medical Instruments Co., Ltd. — FDA 510(k) Submissions

Alton (Shanghai) Medical Instruments Co., Ltd. has submitted 6 FDA 510(k) premarket notifications since 2023, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Endoscope Channel Accessory, Bronchoscope Accessory, Gastroscope And Accessories, Flexible/rigid, Stent, Ureteral, Endoscopic Injection Needle, Gastroenterology-urology . Use the specialty filter in the sidebar to narrow results.

6 devices
1–6 of 6
Ureteral Stents (AF-D series)
K243039 · FAD Stent, Ureteral · Gastroenterology & Urology
Jun 2025 264d
Endoscopic Distal Attachment (AF-D series)
K242635 · FDS Gastroscope And... · Gastroenterology & Urology
May 2025 269d
Disposable Cytology Brush (AF series)
K241679 · KTI Bronchoscope Accessory · Anesthesiology
Mar 2025 266d
Disposable Endoscope Valves Set (AF series)
K241285 · ODC Endoscope Channel Accessory · Gastroenterology & Urology
Oct 2024 147d
Disposable Hemoclip (AF series)
K231633 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Jan 2024 220d
Disposable Injection Needle AF series
K230925 · FBK Endoscopic Injection... · Gastroenterology & Urology
Sep 2023 177d
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