FDA applicant
Hangzhou AGS MedTech Co., Ltd.
FDA records 19 decisions for Hangzhou AGS MedTech Co., Ltd. (Hangzhou, CN) from 2018 to 2026: 19 510(k) clearances. Most are in product codes PKL (Hemostatic Metal Clip For The Gi Tract) and KNS (Unit, Electrosurgical, Endoscopic (With Or…). Since 2016 its 510(k)s took a median of 263 days from receipt to decision, against 170 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hangzhou AGS MedTech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Hangzhou AGS MedTech Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report