Disposable Stone Extraction Basket— 510(k) K253056

Name: FDA 510(k) clearance K253056
Creator: U.S. Food and Drug Administration
Published: 2026-04-03

Substantially Equivalent

Zhejiang Soudon Medical Technology Co., Ltd.

FDA 510(k) clearance K253056 for Disposable Stone Extraction Basket, Substantially Equivalent on 2026-04-03. Applicant: Zhejiang Soudon Medical Technology Co., Ltd.. Device class: 2.

Summary

Zhejiang Soudon Medical Technology's Disposable Stone Extraction Basket is filed under product code LQR (Dislodger, Stone, Biliary). The name is generic.

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).

Zhejiang Soudon Medical Technology filed from Hangzhou, China. The decision came 193 calendar days after FDA received it (September 22, 2025 to April 3, 2026).

Clearance details

Applicant: Zhejiang Soudon Medical Technology Co., Ltd.
Product code: Product code LQR
Device class: Class 2
Regulation: 21 CFR 876.5010
Advisory panel: Gastroenterology, Urology
Date received: 2025-09-22
Decision date: 2026-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code LQR

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K243807 — Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P2025-03-18
K243471 — Extraction Basket2024-12-16
K240192 — Single-use Extraction Baskets2024-10-15
K230598 — Stone Extraction Baskets2023-09-12
K203322 — SpyGlass Discover Retrieval Basket2021-05-26

More clearances from Zhejiang Soudon Medical Technology Co., Ltd.

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K232442 — Disposable Endoscope Injection Needles2023-11-09
K232476 — Disposable Sphincterotome2023-11-07

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