Cleared Traditional

K240192 - Single-use Extraction Baskets

K240192 is an FDA 510(k) clearance for Single-use Extraction Baskets, manufactured by Scivita 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 265-day FDA review.

K240192 · Scivita Medical Technology Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Oct 2024
Decision
265d
Days
Class 2
Risk

K240192 is an FDA 510(k) clearance for the Single-use Extraction Baskets. Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Scivita Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on October 15, 2024 after a review of 265 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 Scivita Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K240192

510(k) Number K240192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2024
Decision Date October 15, 2024
Days to Decision 265 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
135d slower than avg
Panel avg: 130d · This submission: 265d
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 K240192.
Disposable Stone Extraction Basket
K253056 · Zhejiang Soudon Medical Technology Co., Ltd. · Apr 2026
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
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