Hangzhou AGS MedTech Co., Ltd.: FDA clearances and approvals
Hangzhou AGS MedTech Co., Ltd. has 19 FDA 510(k) clearances (first 2018, latest 2026), across 11 product codes in 1 review panel. Median 510(k) review time: 261 days. Since 2017 its median was 261 days, against 155 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 2 | 234 |
| 2019 | 0 | — |
| 2020 | 5 | 194 |
| 2021 | 2 | 260 |
| 2022 | 3 | 267 |
| 2023 | 2 | 264 |
| 2024 | 0 | — |
| 2025 | 2 | 197 |
| 2026 | 3 | 261 |
Review time against the same product codes
Since 2017, Hangzhou AGS MedTech Co., Ltd.'s cleared 510(k)s took a median 261 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 155 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | 6 | 6 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 3 | 3 |
| FDI | Snare, Flexible | 2 | 2 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 1 | 1 |
| KGE | Forceps, Biopsy, Electric | 1 | 1 |
| LQR | Dislodger, Stone, Biliary | 1 | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Hangzhou AGS MedTech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254069 | Hemoclip (511 series, 543 series) | PKL | 2026-08-10 | 235 |
| 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 | 2026-06-24 | 267 |
| K252270 | Hemoclip | PKL | 2026-04-08 | 261 |
| K252271 | Hemoclip | PKL | 2025-11-12 | 114 |
| K241704 | Endoscopic Water Pump | OCX | 2025-03-20 | 280 |
| K222421 | Sphincterotome | KNS | 2023-05-03 | 265 |
| K221713 | Polypectomy Snare | FDI | 2023-03-03 | 263 |
| K213143 | Hemoclip | PKL | 2022-07-12 | 288 |
| K213578 | Balloon Dilatation Catheter | FDF | 2022-04-06 | 147 |
| K211787 | Hemoclip | PKL | 2022-03-03 | 267 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hangzhou AGS MedTech Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Hangzhou AGS MedTech Co., Ltd. have?
Hangzhou AGS MedTech Co., Ltd. has 19 FDA 510(k) clearances (first 2018, latest 2026), across 11 product codes in 1 review panel.
How long does FDA take to clear Hangzhou AGS MedTech Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Hangzhou AGS MedTech Co., Ltd.'s cleared 510(k)s is 261 days. Since 2017: 261 days, versus 155 days for all cleared 510(k)s in the same product codes.
What devices does Hangzhou AGS MedTech Co., Ltd. make?
Its most frequent FDA product codes are PKL (Hemostatic Metal Clip For The Gi Tract, 6); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 3); FDI (Snare, Flexible, 2).
Has Hangzhou AGS MedTech Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hangzhou AGS MedTech Co., Ltd. Related entities may recall under other names.
Next steps
- See all 19 Hangzhou AGS MedTech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code PKL, Hangzhou AGS MedTech Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.