Cleared Traditional

K974018 - WILSON-COOK 10 SHOT MULTI-BAND LIGATOR

K974018 is the FDA 510(k) clearance for WILSON-COOK 10 SHOT MULTI-BAND LIGATOR by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FHN) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K974018 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Jan 1998
Decision
90d
Days
Class 2
Risk

K974018 is an FDA 510(k) clearance for the WILSON-COOK 10 SHOT MULTI-BAND LIGATOR. Classified as Ligator, Hemorrhoidal (product code FHN), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on January 20, 1998 after a review of 90 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

Submission Details

510(k) Number K974018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1997
Decision Date January 20, 1998
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FHN Ligator, Hemorrhoidal
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.

Regulatory Peers - FHN Ligator, Hemorrhoidal

All 9
Devices cleared under the same product code (FHN) and FDA review panel - the closest regulatory comparables to K974018.
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
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K000397 · Boston Scientific Corp · Mar 2000
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K981669 · Boston Scientific Corp · Jun 1998
SPEEDBAND MULTIPLE BAND LIGATOR
K964079 · Boston Scientific Corp · Feb 1997
SPEEDBAND
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K882297 · American Medical Systems, Inc. · Jun 1988