Cleared Traditional

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) - FDA 510(k) Clearance

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

K171969 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
271d
Days
Class 2
Risk

K171969 is an FDA 510(k) clearance for the Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, .... Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on March 28, 2018 after a review of 271 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 Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K171969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2017
Decision Date March 28, 2018
Days to Decision 271 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
141d slower than avg
Panel avg: 130d · This submission: 271d
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 K171969.
Disposable Stone Extraction basket
K201509 · Hangzhou AGS MedTech Co., Ltd. · Dec 2020
Stonetome Stone Removal Device
K191789 · Boston Scientific Corporation · Jul 2019
Wilson-Cook Mini Basket
K182381 · Wilson-Cook Medical, Inc. · Oct 2018
Nathanson Transcystic Bile Duct Stone Exploration Pack
K171915 · Cook Incorporated · Mar 2018
Strange Bile Duct Stone Exploration Set
K173687 · Cook Incorporated · Dec 2017
Wittich Nitinol Stone Basket
K170898 · Cook Incorporated · Dec 2017