Cleared Traditional

K253056 - Disposable Stone Extraction Basket

K253056 is an FDA 510(k) clearance for Disposable Stone Extraction Basket, manufactured by Zhejiang Soudon Medical Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code LQR cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K253056 · Zhejiang Soudon Medical Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
193d
Days
Class 2
Risk

K253056 is an FDA 510(k) clearance for the Disposable Stone Extraction Basket. Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Zhejiang Soudon Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on April 3, 2026 after a review of 193 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhejiang Soudon Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K253056

510(k) Number K253056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2025
Decision Date April 03, 2026
Days to Decision 193 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 131d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQR Device Classification - Class 2, Special Controls

Product Code LQR Dislodger, Stone, Biliary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Shanghai Vanhe Consulting Co., Ltd.
Nick Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LQR Dislodger, Stone, Biliary

All 33
Devices cleared under the same product code (LQR) and FDA review panel - the closest regulatory comparables to K253056.
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
K243807 · Olympus Medical Systems Corp. · Mar 2025
Extraction Basket
K243471 · Micro-Tech (Nanjing) Co., Ltd. · Dec 2024
Single-use Extraction Baskets
K240192 · Scivita Medical Technology Co., Ltd. · Oct 2024
Stone Extraction Baskets
K230598 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Sep 2023
SpyGlass Discover Retrieval Basket
K203322 · Boston Scientific Corporation · May 2021
Disposable Stone Extraction basket
K201509 · Hangzhou AGS MedTech Co., Ltd. · Dec 2020