Cleared Traditional

K023903 - WILSON-COOK ENDOSCOPIC CLIPPING DEVICE

K023903 is an FDA 510(k) clearance for WILSON-COOK ENDOSCOPIC CLIPPING DEVICE, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PKL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K023903 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
90d
Days
Class 2
Risk

K023903 is an FDA 510(k) clearance for the WILSON-COOK ENDOSCOPIC CLIPPING DEVICE. Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on February 20, 2003 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

FDA 510(k) Submission Details - K023903

510(k) Number K023903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2002
Decision Date February 20, 2003
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
41d faster than avg
Panel avg: 131d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PKL Device Classification - Class 2, Special Controls

Product Code PKL Hemostatic Metal Clip For The Gi Tract
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4400
Definition Clip Placement Within The Gastrointestinal (gi) Tract For The Purpose Of Endoscopic Marking, Hemostasis For Mucosal/sub-mucosal Defects, Bleeding Ulcers, Arteries, Polyps, Diverticula In The Colon, Prophylactic Clipping, Anchoring Feeding Tubes, Supplemental Closure Method Of Luminal Perforations.
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 - PKL Hemostatic Metal Clip For The Gi Tract

All 61
Devices cleared under the same product code (PKL) and FDA review panel - the closest regulatory comparables to K023903.
PADLOCK CLIP-12
K120814 · Aponos Medical Corp. · Sep 2012
DISPOSABLE HEMOSTASIS CHIP
K121505 · Wilson-Cook Medical Inc./Cook Endoscopy · Aug 2012
RESOLUTION II CLIP
K102764 · Boston Scientific Corporation · Dec 2010
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS
K990687 · Olympus Optical, Co. · Mar 1999
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
K963160 · Olympus America, Inc. · Jun 1997