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.

Summary

Hangzhou AGS MedTech's Single-use Balloon Dilatation Catheter is filed under FGE, stents, drains, and dilators for the biliary ducts. The device name lists 30 model numbers in the AG-5251 series and ends without a closing parenthesis, so the list may be cut off.

Class II, 21 CFR 876.5010. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

AGS MedTech filed from Hangzhou, China. The decision came 267 calendar days after receipt (September 30, 2025 to June 24, 2026).

Clearance details

Applicant: Hangzhou AGS MedTech Co., Ltd.
Product code: Product 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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K254179 — Drainage Catheter2026-09-18
K262913 — Protégé EverFlex Self-expanding Peripheral Stent System2026-09-17
K260835 — ARCHIMEDES Biodegradable Stent (Medium)2026-07-27
K253832 — Dilation Balloon Catheter2026-04-24
K251658 — Endoflux Biliary & Pancreatic Stent Sets2026-04-16

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.