Cleared Traditional

Disposable Stone Extraction basket (K201509) - FDA 510(k) Clearance

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

K201509 · Hangzhou AGS MedTech Co., Ltd. · Gastroenterology & Urology device
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Dec 2020
Decision
194d
Days
Class 2
Risk

K201509 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 Hangzhou AGS MedTech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on December 16, 2020 after a review of 194 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 Hangzhou AGS MedTech Co., Ltd. devices

Submission Details

510(k) Number K201509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2020
Decision Date December 16, 2020
Days to Decision 194 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
64d slower than avg
Panel avg: 130d · This submission: 194d
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 22
Devices cleared under the same product code (LQR) and FDA review panel - the closest regulatory comparables to K201509.
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
Stonetome Stone Removal Device
K191789 · Boston Scientific Corporation · Jul 2019
Wilson-Cook Mini Basket
K182381 · Wilson-Cook Medical, Inc. · Oct 2018
Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket
K171969 · Wilson-Cook Medical, Inc. · Mar 2018