Cleared Traditional

K904472 - GLASSMAN STONE EXTRACTION SET

K904472 is the FDA 510(k) clearance for GLASSMAN STONE EXTRACTION SET 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 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

Submission Details

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
42d faster than avg
Panel avg: 130d · This submission: 88d
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 K904472.
ENDOSCOPIC BILIARY CATHETER
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