Cleared Traditional

WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR (K953951) - FDA 510(k) Clearance

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

K953951 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 1995
Decision
28d
Days
Class 2
Risk

K953951 is an FDA 510(k) clearance for the WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR. Classified as Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (product code GCA), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on September 19, 1995 after a review of 28 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 K953951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1995
Decision Date September 19, 1995
Days to Decision 28 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
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 - GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

All 25
Devices cleared under the same product code (GCA) and FDA review panel - the closest regulatory comparables to K953951.
Disposable Stone Retrieval Balloon Catheter
K253013 · Zhejiang Soudon Medical Technology Co., Ltd. · May 2026
Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
K232752 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Feb 2024
SpyGlass Discover Balloon Dilation Catheter
K212582 · Boston Scientific Corporation · May 2022
Stone Retrieval Balloon Catheter
K210660 · Anrei Medical (Hangzhou) Co., Ltd. · Apr 2021
Stone Retrieval Balloon
K200173 · Hangzhou AGS MedTech Co., Ltd. · May 2020
Fusion Quattro Extraction Balloon
K200247 · Wilson-Cook Medical, Inc. · Feb 2020