Cleared Traditional

K944220 - WILSON COOK MULTIPLE BAND LIGATOR

K944220 is an FDA 510(k) clearance for WILSON COOK MULTIPLE BAND LIGATOR, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MND cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K944220 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jan 1995
Decision
148d
Days
Class 2
Risk

K944220 is an FDA 510(k) clearance for the WILSON COOK MULTIPLE BAND LIGATOR. Classified as Ligator, Esophageal (product code MND), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on January 24, 1995 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4400 - 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

FDA 510(k) Submission Details - K944220

510(k) Number K944220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1994
Decision Date January 24, 1995
Days to Decision 148 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
17d slower than avg
Panel avg: 131d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MND Device Classification - Class 2, Special Controls

Product Code MND Ligator, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4400
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.