# K253056: Disposable Stone Extraction Basket

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Soudon Medical Technology Co., Ltd.
- Decided: Apr 3, 2026 after 193 days
- Product code: LQR (Dislodger, Stone, Biliary)
- 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 K851965 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201509: Disposable Stone Extraction basket, Hangzhou AGS MedTech Co., Ltd. (2020) Summary page 5.

## Indications for use
The device is used for the endoscopic removal of biliary stones and foreign bodies in the biliary system. The device is indicated for use in adult patient.

Source page: https://510kreport.com/device/K253056
Methodology: https://510kreport.com/methodology