Cleared Traditional

K050502 - SINGLE USE BALLOON DILATOR MAXPASSTM

K050502 is the FDA 510(k) clearance for SINGLE USE BALLOON DILATOR MAXPASSTM by Olympus Winter & Ibe GmbH. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K050502 · Olympus Winter & Ibe GmbH · Gastroenterology & Urology device
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Jul 2005
Decision
130d
Days
Class 2
Risk

K050502 is an FDA 510(k) clearance for the SINGLE USE BALLOON DILATOR MAXPASSTM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Olympus Winter & Ibe GmbH (Melville, US). The FDA issued a Cleared decision on July 8, 2005 after a review of 130 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 Olympus Winter & Ibe GmbH devices

Submission Details

510(k) Number K050502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2005
Decision Date July 08, 2005
Days to Decision 130 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
At panel average
Panel avg: 130d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 298
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K050502.
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ZILVER 635 BILIARY STENT
K051124 · Cook, Inc. · Jul 2005
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050534 · Abbott Laboratories · May 2005
PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
K050777 · Conmedcorp · Apr 2005
MODIFICATION TO:ZILVER 518 BILIARY STENT
K050698 · Cook, Inc. · Mar 2005