Cleared Traditional

K903858 - COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION

K903858 is an FDA 510(k) clearance for COOK-GIANTURCO ROSCH BILIARY Z-STENT, manufactured by Cook, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K903858 · Cook, Inc. · Gastroenterology & Urology device
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Oct 1990
Decision
51d
Days
Class 2
Risk

K903858 is an FDA 510(k) clearance for the COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on October 10, 1990 after a review of 51 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 Cook, Inc. devices

FDA 510(k) Submission Details - K903858

510(k) Number K903858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1990
Decision Date October 10, 1990
Days to Decision 51 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
80d faster than avg
Panel avg: 131d · This submission: 51d
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 395
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K903858.
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS
K905229 · Arrow Intl., Inc. · Jan 1991
ZIMMON ENDOSCOPIC PANCREATIC STENT
K900923 · Wilson-Cook Medical, Inc. · Oct 1990
SOEHENDRA STENT RETRIEVER
K903420 · Wilson-Cook Medical, Inc. · Oct 1990
PR CANNULAS
K902734 · Olympus Corp. · Aug 1990
WILSON-COOK SYRINGE HOLDERS
K902107 · Wilson-Cook Medical, Inc. · Jul 1990
BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON
K901427 · Telemed Systems, Inc. · Jun 1990