Cleared Traditional

K904472 - GLASSMAN STONE EXTRACTION SET

K904472 is an FDA 510(k) clearance for GLASSMAN STONE EXTRACTION SET, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LQR cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K904472 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Dec 1990
Decision
88d
Days
Class 2
Risk

K904472 is an FDA 510(k) clearance for the GLASSMAN STONE EXTRACTION SET. 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 December 28, 1990 after a review of 88 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

FDA 510(k) Submission Details - K904472

510(k) Number K904472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1990
Decision Date December 28, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 131d · This submission: 88d
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 33
Devices cleared under the same product code (LQR) and FDA review panel - the closest regulatory comparables to K904472.
MICROVASIVE INSURG HELICAL & MINI-HELICAL BASKETS
K925495 · Boston Scientific Corp · Dec 1992
BILIARY STONE DISLODGER
K925559 · Annex Medical, Inc. · Dec 1992
OVER THE WIRE STONE BASKET
K915538 · Medical Dynamics, Inc. · Mar 1992
WITTICH NITINOL STONE BASKET
K902944 · Cook, Inc. · Sep 1990
COPE NITINOL STONE BASKET
K902945 · Cook, Inc. · Sep 1990
WILTEK BALLOON STONE EXTRACTOR
K894865 · Wiltek Medical, Inc. · Dec 1989