510(k) K253393 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
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-52
| Applicant | Hangzhou AGS MedTech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Jun 24, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253393
No recall in the FDA data names this 510(k).
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