Medical Device Manufacturer · CN , Hangzhou

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

19 submissions · 19 cleared · Since 2018

Recent clearances: Hemoclip (511 series, 543 series), Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019, Hemoclip

19
Total
19
Cleared
0
Denied

FDA 510(k) Regulatory Record - Hangzhou AGS MedTech Co., Ltd. Gastroenterology & Urology ✕

19 devices
1-12 of 19
Cleared Aug 10, 2026
Hemoclip (511 series, 543 series)
K254069 · PKL
Gastroenterology & Urology · 235d
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
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