Cleared Traditional

K201509 - Disposable Stone Extraction basket

K201509 is an FDA 510(k) clearance for Disposable Stone Extraction basket, manufactured by Hangzhou AGS MedTech Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code LQR cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K201509 · Hangzhou AGS MedTech Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K201509

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.

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 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