Cleared Traditional

K230598 - Stone Extraction Baskets (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 37
Devices cleared under the same product code (LQR) and FDA review panel - the closest regulatory comparables to K230598.
Disposable Stone Extraction Basket
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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