# Hangzhou AGS MedTech Co., Ltd.

- Location (FDA's records): Hangzhou, CN
- FDA decisions: 19 (2018–2026): 19 510(k) clearances
- Product codes: PKL (6), KNS (3), FDI (2), GCA (1), FDF (1), LQR (1), FBK (1), ODC (1), KGE (1), OCX (1), FGE (1)
- 510(k) review time since 2016: median 263 days, against 170 for FDA's reviews in the same codes and years (1 of 14 faster)
- Predicates its devices cite: 25 (6 its own); citations of its devices by later devices: 19 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 5 (https://510kreport.com/company/boston-scientific)
- Wilson-Cook Medical, Inc.: 4 (https://510kreport.com/company/wilson-cook-medical)
- Micro-Tech (Nanjing) Co., Ltd.: 4 (https://510kreport.com/company/micro-tech-nanjing)
- Olympus Medical Systems Corp.: 3 (https://510kreport.com/company/olympus-medical-systems)
- Wilson-Cook Medical Inc./Cook Endoscopy: 1 (https://510kreport.com/company/wilson-cook-medical-cook-endoscopy)
- Erbe USA, Inc.: 1 (https://510kreport.com/company/erbe-usa)
- Keymed (Medical & Industrial Equipment), Ltd.: 1 (https://510kreport.com/company/keymed-medical-industrial-equipment)

## Firms that cite its devices most
- Zhejiang Soudon Medical Technology Co., Ltd.: 5 (https://510kreport.com/company/zhejiang-soudon-medical-technology)
- Yangzhou Fartley Medical Instrument Technology Co., Ltd.: 2 (https://510kreport.com/company/yangzhou-fartley-medical-instrument-technology)
- Anrei Medical (Hangzhou) Co., Ltd.: 1 (https://510kreport.com/company/anrei-medical-hangzhou)
- Alton (Shanghai) Medical Instruments Co., Ltd.: 1 (https://510kreport.com/company/alton-shanghai-medical-instruments)
- Jiangxi Zhuoruihua Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/jiangxi-zhuoruihua-medical-instrument)
- Zhejiang Chuangxiang Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-chuangxiang-medical-technology)
- Finemedix Co., Ltd.: 1 (https://510kreport.com/company/finemedix)
- Promisemed Hangzhou Meditech Co., Ltd.: 1 (https://510kreport.com/company/promisemed-hangzhou-meditech)

## Its most-cited devices
- K172727: Hemoclip (2018), cited by 6
- K172729: Polypectomy Snare (2018), cited by 4
- K200173: Stone Retrieval Balloon (2020), cited by 2
- K201121: Sphincterotome (2021), cited by 2
- K211787: Hemoclip (2022), cited by 2
- K190032: Disposable Sclerotherapy Needle (2020), cited by 2

## Recent decisions
- K254069: Hemoclip (511 series, 543 series) (Aug 10, 2026)
- 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 (Jun 24, 2026)
- K252270: Hemoclip (Apr 8, 2026)
- K252271: Hemoclip (Nov 12, 2025)
- K241704: Endoscopic Water Pump (Mar 20, 2025)
- K222421: Sphincterotome (May 3, 2023)
- K221713: Polypectomy Snare (Mar 3, 2023)
- K213143: Hemoclip (Jul 12, 2022)

Source page: https://510kreport.com/company/hangzhou-ags-medtech