Medical Device Manufacturer · CN , Hangzhou

Hangzhou AGS MedTech Co., Ltd. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2018
16
Total
16
Cleared
0
Denied

FDA 510(k) cleared devices by Hangzhou AGS MedTech Co., Ltd. Gastroenterology & Urology ✕

16 devices
1-12 of 16
Cleared Nov 12, 2025
Hemoclip
K252271 · PKL
Gastroenterology & Urology · 114d
Cleared Mar 20, 2025
Endoscopic Water Pump
K241704 · OCX
Gastroenterology & Urology · 280d
Cleared May 03, 2023
Sphincterotome
K222421 · KNS
Gastroenterology & Urology · 265d
Cleared Mar 03, 2023
Polypectomy Snare
K221713 · FDI
Gastroenterology & Urology · 263d
Cleared Jul 12, 2022
Hemoclip
K213143 · PKL
Gastroenterology & Urology · 288d
Cleared Apr 06, 2022
Balloon Dilatation Catheter
K213578 · FDF
Gastroenterology & Urology · 147d
Cleared Mar 03, 2022
Hemoclip
K211787 · PKL
Gastroenterology & Urology · 267d
Cleared Oct 05, 2021
Bipolar Coagulation Foreceps
K210406 · KGE
Gastroenterology & Urology · 237d
Cleared Feb 05, 2021
Sphincterotome
K201121 · KNS
Gastroenterology & Urology · 284d
Cleared Dec 23, 2020
Locking device
K202237 · ODC
Gastroenterology & Urology · 138d
Cleared Dec 16, 2020
Disposable Stone Extraction basket
K201509 · LQR
Gastroenterology & Urology · 194d
Cleared May 21, 2020
Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy...
K192342 · KNS
Gastroenterology & Urology · 267d
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