Medical Device Manufacturer · CN , Hangzhou

Hangzhou AGS MedTech Co., Ltd.

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

Hangzhou AGS MedTech Co., Ltd. — FDA 510(k) Submissions

Hangzhou AGS MedTech Co., Ltd. has submitted 16 FDA 510(k) premarket notifications since 2018, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hemostatic Metal Clip For The Gi Tract, Unit, Electrosurgical, Endoscopic (with Or Without Accessories), Snare, Flexible, Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection, Dislodger, Stone, Biliary . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
Hemoclip
K252271 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Nov 2025 114d
Endoscopic Water Pump
K241704 · OCX Endoscopic... · Gastroenterology & Urology
Mar 2025 280d
Sphincterotome
K222421 · KNS Unit, Electrosurgical,... · Gastroenterology & Urology
May 2023 265d
Polypectomy Snare
K221713 · FDI Snare, Flexible · Gastroenterology & Urology
Mar 2023 263d
Hemoclip
K213143 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Jul 2022 288d
Balloon Dilatation Catheter
K213578 · FDF Colonoscope And... · Gastroenterology & Urology
Apr 2022 147d
Hemoclip
K211787 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Mar 2022 267d
Bipolar Coagulation Foreceps
K210406 · KGE Forceps, Biopsy, Electric · Gastroenterology & Urology
Oct 2021 237d
Sphincterotome
K201121 · KNS Unit, Electrosurgical,... · Gastroenterology & Urology
Feb 2021 284d
Locking device
K202237 · ODC Endoscope Channel Accessory · Gastroenterology & Urology
Dec 2020 138d
Disposable Stone Extraction basket
K201509 · LQR Dislodger, Stone, Biliary · Gastroenterology & Urology
Dec 2020 194d
Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)
K192342 · KNS Unit, Electrosurgical,... · Gastroenterology & Urology
May 2020 267d
Stone Retrieval Balloon
K200173 · GCA Biliary Catheter For... · Gastroenterology & Urology
May 2020 99d
Disposable Sclerotherapy Needle
K190032 · FBK Endoscopic Injection... · Gastroenterology & Urology
Feb 2020 416d
Polypectomy Snare
K172729 · FDI Snare, Flexible · Gastroenterology & Urology
May 2018 252d
Hemoclip
K172727 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Apr 2018 217d
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