Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hangzhou AGS MedTech Co., Ltd. · Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
263 daysmedian FDA review time
288 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-52 | Hangzhou AGS MedTech Co., Ltd. | 2026-06-24 | 267 | 0 |
| K252270 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2026-04-08 | 261 | 0 |
| K252271 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2025-11-12 | 114 | 0 |
| K241704 | Endoscopic Water Pump | Hangzhou AGS MedTech Co., Ltd. | 2025-03-20 | 280 | 0 |
| K222421 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2023-05-03 | 265 | 0 |
| K221713 | Polypectomy Snare | Hangzhou AGS MedTech Co., Ltd. | 2023-03-03 | 263 | 0 |
| K213143 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2022-07-12 | 288 | 0 |
| K213578 | Balloon Dilatation Catheter | Hangzhou AGS MedTech Co., Ltd. | 2022-04-06 | 147 | 0 |
| K211787 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2022-03-03 | 267 | 0 |
| K210406 | Bipolar Coagulation Foreceps | Hangzhou AGS MedTech Co., Ltd. | 2021-10-05 | 237 | 0 |
| K201121 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2021-02-05 | 284 | 0 |
| K202237 | Locking device | Hangzhou AGS MedTech Co., Ltd. | 2020-12-23 | 138 | 0 |
| K201509 | Disposable Stone Extraction basket | Hangzhou AGS MedTech Co., Ltd. | 2020-12-16 | 194 | 0 |
| K192342 | Electrosurgical System (Electrosurgical Generator with Bipol | Hangzhou AGS MedTech Co., Ltd. | 2020-05-21 | 267 | 0 |
| K200173 | Stone Retrieval Balloon | Hangzhou AGS MedTech Co., Ltd. | 2020-05-01 | 99 | 0 |
| K190032 | Disposable Sclerotherapy Needle | Hangzhou AGS MedTech Co., Ltd. | 2020-02-27 | 416 | 0 |
| K172729 | Polypectomy Snare | Hangzhou AGS MedTech Co., Ltd. | 2018-05-21 | 252 | 0 |
| K172727 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2018-04-16 | 217 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda