Cleared Special

K020526 - MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR

K020526 is an FDA 510(k) clearance for MODIFICATION TO WILSON-COOK MULTIPLE BA..., manufactured by Don Wilson/Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FHN cleared through the Special 510(k) pathway after a 28-day FDA review.

K020526 · Don Wilson/Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
28d
Days
Class 2
Risk

K020526 is an FDA 510(k) clearance for the MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR. Classified as Ligator, Hemorrhoidal (product code FHN), Class II - Special Controls.

Submitted by Don Wilson/Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on March 19, 2002 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 876.4400 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K020526

510(k) Number K020526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2002
Decision Date March 19, 2002
Days to Decision 28 days
Submission Type Special
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
103d faster than avg
Panel avg: 131d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

FHN Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (FHN) and FDA review panel - the closest regulatory comparables to K020526.
HAEMOBAND MULTI-LIGATOR
K091519 · Haemoband Surgical, Ltd. · Jul 2009
LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
K070881 · Sapimed S.P.A. · Sep 2007
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
K020824 · Boston Scientific Corp · Apr 2002
RIZA BAND STRETCHER (RBS)-60000
K001236 · R-Med, Inc. · Jul 2000
ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER
K000297 · Erchinger Medizintecnik · Apr 2000
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K000397 · Boston Scientific Corp · Mar 2000
K020526 · MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
Download PDF FDA Summary Don Wilson/Wilson-Coo…