Company ยท CN
Hangzhou AGS MedTech Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (4 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | 6 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 3 |
| FDI | Snare, Flexible | 2 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 1 |
| KGE | Forceps, Biopsy, Electric | 1 |
| LQR | Dislodger, Stone, Biliary | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 |
| ODC | Endoscope Channel Accessory | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 2026 | K254069 | Hemoclip (511 series, 543 series) Hangzhou AGS MedTech Co., Ltd., CN | PKL |
| Jun 24, 2026 | K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-52 Hangzhou AGS MedTech Co., Ltd., CN | FGE |
| Apr 8, 2026 | K252270 | Hemoclip Hangzhou AGS MedTech Co., Ltd., CN | PKL |
| Nov 12, 2025 | K252271 | Hemoclip Hangzhou AGS MedTech Co., Ltd., CN | PKL |
| Mar 20, 2025 | K241704 | Endoscopic Water Pump Hangzhou AGS MedTech Co., Ltd., CN | OCX |
| May 3, 2023 | K222421 | Sphincterotome Hangzhou AGS MedTech Co., Ltd., CN | KNS |
| Mar 3, 2023 | K221713 | Polypectomy Snare Hangzhou AGS MedTech Co., Ltd., CN | FDI |
| Jul 12, 2022 | K213143 | Hemoclip Hangzhou AGS MedTech Co., Ltd., CN | PKL |
| Apr 6, 2022 | K213578 | Balloon Dilatation Catheter Hangzhou AGS MedTech Co., Ltd., CN | FDF |
| Mar 3, 2022 | K211787 | Hemoclip Hangzhou AGS MedTech Co., Ltd., CN | PKL |
| Oct 5, 2021 | K210406 | Bipolar Coagulation Foreceps Hangzhou AGS MedTech Co., Ltd., CN | KGE |
| Feb 5, 2021 | K201121 | Sphincterotome Hangzhou AGS MedTech Co., Ltd., CN | KNS |
| Dec 23, 2020 | K202237 | Locking device Hangzhou AGS MedTech Co., Ltd., CN | ODC |
| Dec 16, 2020 | K201509 | Disposable Stone Extraction basket Hangzhou AGS MedTech Co., Ltd., CN | LQR |
| May 21, 2020 | K192342 | Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgi Hangzhou AGS MedTech Co., Ltd., CN | KNS |
| May 1, 2020 | K200173 | Stone Retrieval Balloon Hangzhou AGS MedTech Co., Ltd., CN | GCA |
| Feb 27, 2020 | K190032 | Disposable Sclerotherapy Needle Hangzhou AGS MedTech Co., Ltd., CN | FBK |
| May 21, 2018 | K172729 | Polypectomy Snare Hangzhou AGS MedTech Co., Ltd., CN | FDI |
| Apr 16, 2018 | K172727 | Hemoclip Hangzhou AGS MedTech Co., Ltd., CN | PKL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||