Medical Device Manufacturer · CN , Shanghai

Alton (Shanghai) Medical Instruments Co., Ltd. - FDA 510(k) Cleared D...

6 submissions · 6 cleared · Since 2023

Recent clearances: Ureteral Stents (AF-D series), Endoscopic Distal Attachment (AF-D series), Disposable Cytology Brush (AF series)

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Alton (Shanghai) Medical Instruments Co., Ltd. Gastroenterology & Urology ✕

5 devices

1-5 of 5

Cleared Jun 18, 2025

Ureteral Stents (AF-D series)

Gastroenterology & Urology · 264d

Cleared May 30, 2025

Endoscopic Distal Attachment (AF-D series)

Gastroenterology & Urology · 269d

Cleared Oct 01, 2024

Disposable Endoscope Valves Set (AF series)

Gastroenterology & Urology · 147d

Cleared Jan 11, 2024

Disposable Hemoclip (AF series)

Gastroenterology & Urology · 220d

Cleared Sep 27, 2023

Disposable Injection Needle AF series

Gastroenterology & Urology · 177d