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— 510(k) K253393

Name: FDA 510(k) clearance K253393
Creator: U.S. Food and Drug Administration
Published: 2026-06-24

Substantially Equivalent

Hangzhou AGS MedTech Co., Ltd.

FDA 510(k) clearance K253393 for 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, Substantially Equivalent on 2026-06-24. Applicant: Hangzhou AGS MedTech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hangzhou AGS MedTech Co., Ltd.
Product code: Code FGE
Device class: Class 2
Regulation: 21 CFR 876.5010
Advisory panel: Gastroenterology, Urology
Date received: 2025-09-30
Decision date: 2026-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FGE

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K260835 — ARCHIMEDES Biodegradable Stent (Medium)2026-07-27
K253832 — Dilation Balloon Catheter2026-04-24
K251658 — Endoflux Biliary & Pancreatic Stent Sets2026-04-16
K253987 — BARE Wireguided Balloon Dilation Catheter (1235)2026-03-13
K253132 — Single use stone retrieval balloons2026-03-06

More clearances from Hangzhou AGS MedTech Co., Ltd.

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K254069 — Hemoclip (511 series, 543 series)2026-08-10
K252270 — Hemoclip2026-04-08
K252271 — Hemoclip2025-11-12
K241704 — Endoscopic Water Pump2025-03-20
K222421 — Sphincterotome2023-05-03

Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.