Cleared Traditional

K101095 - DIRECT PERORAL CHOLANGIOSCOPY BALLOON

K101095 is an FDA 510(k) clearance for DIRECT PERORAL CHOLANGIOSCOPY BALLOON, 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 90-day FDA review.

K101095 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Jul 2010
Decision
90d
Days
Class 2
Risk

K101095 is an FDA 510(k) clearance for the DIRECT PERORAL CHOLANGIOSCOPY BALLOON. 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 July 19, 2010 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 876.5010 - 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: 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 - K101095

510(k) Number K101095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2010
Decision Date July 19, 2010
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.

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 388
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K101095.
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BONASTENT BILIARY
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K093947 · Merit Medical Systems, Inc. · Jan 2010
MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
K093392 · Navilyst Medical, Inc. · Dec 2009