Medical Device Manufacturer · CN , Hangzhou

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

18 submissions · 18 cleared · Since 2018

Recent clearances: Hemoclip, Hemoclip, Endoscopic Water Pump

18
Total
18
Cleared
0
Denied

Hangzhou AGS MedTech Co., Ltd. has 18 FDA 510(k) cleared gastroenterology & urology devices. Based in Hangzhou, CN.

Latest FDA clearance: Jun 2026. Active since 2018.

Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Shanghai Thinkwell Consulting Co., Ltd. as regulatory consultant.

FDA 510(k) Regulatory Record - Hangzhou AGS MedTech Co., Ltd.

18 devices
1-18 of 18
Cleared Jun 24, 2026
Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518...
K253393 · FGE
Gastroenterology & Urology · 267d
Cleared Apr 08, 2026
Hemoclip
K252270 · PKL
Gastroenterology & Urology · 261d
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
Cleared May 01, 2020
Stone Retrieval Balloon
K200173 · GCA
Gastroenterology & Urology · 99d
Cleared Feb 27, 2020
Disposable Sclerotherapy Needle
K190032 · FBK
Gastroenterology & Urology · 416d
Cleared May 21, 2018
Polypectomy Snare
K172729 · FDI
Gastroenterology & Urology · 252d
Cleared Apr 16, 2018
Hemoclip
K172727 · PKL
Gastroenterology & Urology · 217d
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