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.

Clearance details

Applicant: Zhejiang Soudon Medical Technology Co., Ltd.
Product code: 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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K253013 — Disposable Stone Retrieval Balloon Catheter2026-05-08
K232450 — Disposable Hemostatic Clips2024-01-26
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.