# K253132: Single use stone retrieval balloons

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
- Decided: Mar 6, 2026 after 162 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: 3 generations back to K931619 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211021: Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible, Micro-Tech (Nanjing) Co., Ltd. (2022) Summary page 5.

## Indications for use
The Retrieval Balloon is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon. The device is for adult use only.

Source page: https://510kreport.com/device/K253132
Methodology: https://510kreport.com/methodology