Cleared Traditional

K182381 - Wilson-Cook Mini Basket

K182381 is the FDA 510(k) clearance for Wilson-Cook Mini Basket by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code LQR) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K182381 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Oct 2018
Decision
60d
Days
Class 2
Risk

K182381 is an FDA 510(k) clearance for the Wilson-Cook Mini 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 October 30, 2018 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K182381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2018
Decision Date October 30, 2018
Days to Decision 60 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
70d faster than avg
Panel avg: 130d · This submission: 60d
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 24
Devices cleared under the same product code (LQR) and FDA review panel - the closest regulatory comparables to K182381.
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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
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Strange Bile Duct Stone Exploration Set
K173687 · Cook Incorporated · Dec 2017