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Data / Medical devices / China / Hangzhou AGS MedTech Co., Ltd.

Hangzhou AGS MedTech Co., Ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 19 510(k) clearances

Hangzhou AGS MedTech Co., Ltd. is registered with the FDA (registration 3010288205) in Hangzhou Zhejiang, China. It lists 19 device types. The FDA files 19 510(k) clearances under its listings, the newest dated August 10, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Hangzhou AGS MedTech Co., Ltd.
FDA registration number
3010288205
Address
Building 2,5 and 7, No.389 Xingzhong Road Linping District, Hangzhou Zhejiang, China, 311103
Owner or operator
Hangzhou AGS MedTech Co., Ltd. (10052959)
Roles
Manufacturer, Repackager or relabeler
First device listed
October 29, 2016
Registered through
2026
Brand names listed
/, AGS

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Cleaning Brushes, For EndoscopeMNL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionGCA2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Colonoscope And Accessories, Flexible/RigidFDF2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dilator, EsophagealKNQ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dislodger, Stone, BiliaryLQR2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Endoscope Channel AccessoryODC2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, ExemptPTS2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-UrologyOCY2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-UrologyFBK2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Endoscopic Irrigation/Suction SystemOCX2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, ElectricKGE2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gastroscope And Accessories, Flexible/RigidFDS2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Hemostatic Metal Clip For The Gi TractPKL2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Snare, FlexibleFDI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Snare, Non-ElectricalFGX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Stents, Drains And Dilators For The Biliary DuctsFGE2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS2Manufacturer, Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 10, 2026K254069Hemoclip (511 series, 543 series)PKLSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
June 24, 2026K253393Single-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-5251-128019FGESubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
April 8, 2026K252270HemoclipPKLSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
November 12, 2025K252271HemoclipPKLSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
March 20, 2025K241704Endoscopic Water PumpOCXSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
May 3, 2023K222421SphincterotomeKNSSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
March 3, 2023K221713Polypectomy SnareFDISubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
July 12, 2022K213143HemoclipPKLSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
April 6, 2022K213578Balloon Dilatation CatheterFDFSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
March 3, 2022K211787HemoclipPKLSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
October 5, 2021K210406Bipolar Coagulation ForecepsKGESubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
February 5, 2021K201121SphincterotomeKNSSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
December 23, 2020K202237Locking deviceODCSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
December 16, 2020K201509Disposable Stone Extraction basketLQRSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
May 21, 2020K192342Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)KNSSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
May 1, 2020K200173Stone Retrieval BalloonGCASubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
February 27, 2020K190032Disposable Sclerotherapy NeedleFBKSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
May 21, 2018K172729Polypectomy SnareFDISubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov
April 16, 2018K172727HemoclipPKLSubstantially EquivalentHangzhou AGS MedTech Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated August 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.