Hangzhou AGS MedTech Co., Ltd.
Hangzhou Zhejiang, CN
Hangzhou AGS MedTech Co., Ltd. appears in FDA device records in Hangzhou Zhejiang, CN. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Hangzhou AGS MedTech Co., Ltd. between 2018 and 2026. The busiest year on record is 2020, with 5. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 2 |
| 2020 | 5 |
| 2021 | 2 |
| 2022 | 3 |
| 2023 | 2 |
| 2025 | 2 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254069 | Hemoclip (511 series, 543 series) | PKL | Substantially Equivalent | |
| K253393 | 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 | FGE | Substantially Equivalent | |
| K252270 | Hemoclip | PKL | Substantially Equivalent | |
| K252271 | Hemoclip | PKL | Substantially Equivalent | |
| K241704 | Endoscopic Water Pump | OCX | Substantially Equivalent | |
| K222421 | Sphincterotome | KNS | Substantially Equivalent | |
| K221713 | Polypectomy Snare | FDI | Substantially Equivalent | |
| K213143 | Hemoclip | PKL | Substantially Equivalent | |
| K213578 | Balloon Dilatation Catheter | FDF | Substantially Equivalent | |
| K211787 | Hemoclip | PKL | Substantially Equivalent | |
| K210406 | Bipolar Coagulation Foreceps | KGE | Substantially Equivalent | |
| K201121 | Sphincterotome | KNS | Substantially Equivalent | |
| K202237 | Locking device | ODC | Substantially Equivalent | |
| K201509 | Disposable Stone Extraction basket | LQR | Substantially Equivalent | |
| K192342 | Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) | KNS | Substantially Equivalent | |
| K200173 | Stone Retrieval Balloon | GCA | Substantially Equivalent | |
| K190032 | Disposable Sclerotherapy Needle | FBK | Substantially Equivalent | |
| K172729 | Polypectomy Snare | FDI | Substantially Equivalent | |
| K172727 | Hemoclip | PKL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010288205 | 3010288205 | Hangzhou AGS MedTech Co., Ltd. | Building 2,5 and 7, No.389 Xingzhong Road, Hangzhou Zhejiang 311103 CN | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- FDFColonoscope And Accessories, Flexible/Rigid
- KNQDilator, Esophageal
- LQRDislodger, Stone, Biliary
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- ODCEndoscope Channel Accessory
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- OCXEndoscopic Irrigation/Suction System
- KGEForceps, Biopsy, Electric
- FCLForceps, Biopsy, Non-Electric
- FDSGastroscope And Accessories, Flexible/Rigid
- PKLHemostatic Metal Clip For The Gi Tract
- FDISnare, Flexible
- FGXSnare, Non-Electrical
- FGEStents, Drains And Dilators For The Biliary Ducts
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain