Cleared Traditional

K935094 - BALLOON DILATION CATHETER

K935094 is an FDA 510(k) clearance for BALLOON DILATION CATHETER, 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 459-day FDA review.

K935094 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Jan 1995
Decision
459d
Days
Class 2
Risk

K935094 is an FDA 510(k) clearance for the BALLOON DILATION CATHETER. 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 January 24, 1995 after a review of 459 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Wilson-Cook Medical, Inc. devices

FDA 510(k) Submission Details - K935094

510(k) Number K935094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1993
Decision Date January 24, 1995
Days to Decision 459 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
328d slower than avg
Panel avg: 131d · This submission: 459d
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 K935094.
MS CLASSIQUE BALLOON CATHETER
K944143 · Meadox Surgimed, Inc. · Mar 1995
WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER
K941350 · Wilson-Cook Medical, Inc. · Mar 1995
BILIARY STENT
K943143 · Menlo Care, Inc. · Feb 1995
BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM
K925406 · Schneider Intl., Ltd. · Jan 1995
MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH
K930623 · Boston Scientific Corp · Sep 1994
AMERICAN CATHETER E.R.C.P. CANNULA
K940370 · Intl. Medical, Inc. · Aug 1994