Cleared Traditional

K230598 - Stone Extraction Baskets

K230598 is an FDA 510(k) clearance for Stone Extraction Baskets, manufactured by Jiangsu Vedkang Medical Science and 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.

K230598 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Gastroenterology & Urology device
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Sep 2023
Decision
193d
Days
Class 2
Risk

K230598 is an FDA 510(k) clearance for the Stone Extraction Baskets. Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Jiangsu Vedkang Medical Science and Technology Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on September 12, 2023 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 Jiangsu Vedkang Medical Science and Technology Co., Ltd. devices

FDA 510(k) Submission Details - K230598

510(k) Number K230598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2023
Decision Date September 12, 2023
Days to Decision 193 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 130d · 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 Peers - LQR Dislodger, Stone, Biliary

All 25
Devices cleared under the same product code (LQR) and FDA review panel - the closest regulatory comparables to K230598.
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
SpyGlass Discover Retrieval Basket
K203322 · Boston Scientific Corporation · May 2021
Disposable Stone Extraction basket
K201509 · Hangzhou AGS MedTech Co., Ltd. · Dec 2020
Stonetome Stone Removal Device
K191789 · Boston Scientific Corporation · Jul 2019