Cleared Traditional

K896069 - WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT

K896069 is an FDA 510(k) clearance for WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K896069 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Dec 1989
Decision
50d
Days
Class 2
Risk

K896069 is an FDA 510(k) clearance for the WILSON-COOK GIANTURCO-ROSCH BILIARY Z 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 December 8, 1989 after a review of 50 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wilson-Cook Medical, Inc. devices

FDA 510(k) Submission Details - K896069

510(k) Number K896069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1989
Decision Date December 08, 1989
Days to Decision 50 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 131d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 396
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K896069.
PORGES BILIARY STENTS
K896423 · Porges Corp. · Jan 1990
WILTEK E.R.C.P. CATHETER
K894867 · Wiltek Medical, Inc. · Dec 1989
WILTEK BILIARY STENT SET
K894871 · Wiltek Medical, Inc. · Dec 1989
BILIARY ENDOPROSTHESIS FOR INTERNAL DRAINAGE SET
K892383 · Porges Corp. · May 1989
BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER
K892384 · Porges Corp. · May 1989
BURNEY GALLBLADDER CATHETER KIT
K880343 · Mallinckrodt Critical Care · May 1989