# K253393: 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

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AGS MedTech Co., Ltd.
- Decided: Jun 24, 2026 after 267 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K974788 (1998). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180418: Reliant (TM) Multistage Dilatation Balloon Catheter, Micro-Tech (Nanjing) Co., Ltd. (2018) Summary page 5.

## Indications for use
The Single-use Balloon Dilatation Catheter is intended to endoscopically dilate strictures of the alimentary tract (involving biliary tract). The device is supplied sterile and intended for single use only.

Source page: https://510kreport.com/device/K253393
Methodology: https://510kreport.com/methodology