K253393
- 510(k) number
- K253393
- Device name
- 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
- Applicant
- Hangzhou AGS MedTech Co., Ltd. CN
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2026-06-24
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.3 MB · U.S. public domain
Also available from FDA: K253393.pdf
Official FDA record: K253393
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.