Cleared Special

K990130 - WILSON-COOK PANCREATIC WEDGE STENT

K990130 is an FDA 510(k) clearance for WILSON-COOK PANCREATIC WEDGE STENT, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 29-day FDA review.

K990130 · 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
Feb 1999
Decision
29d
Days
Class 2
Risk

K990130 is an FDA 510(k) clearance for the WILSON-COOK PANCREATIC WEDGE STENT. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on February 12, 1999 after a review of 29 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. 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 - K990130

510(k) Number K990130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1999
Decision Date February 12, 1999
Days to Decision 29 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
102d faster than avg
Panel avg: 131d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 477
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K990130.
CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC
K990631 · Cordis Corp. · Apr 1999
GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
K991032 · Guidant Corp. · Apr 1999
GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38
K983075 · Guidant Corp. · Mar 1999
ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM
K982346 · AngioDynamics, Inc. · Jan 1999
CORDIS NITINOL STENT AND DELIVERY SYSTEM
K980823 · Cordis Corp. · Dec 1998
PERIPHERAL AVE STENT SYSTEM
K983008 · Peripheral Ave · Nov 1998
K990130 · WILSON-COOK PANCREATIC WEDGE STENT
Download PDF FDA Summary Wilson-Cook Medical, …