Cleared Traditional

K904669 - BALLOON CATHETERS

K904669 is an FDA 510(k) clearance for BALLOON CATHETERS, manufactured by Olympus Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K904669 · Olympus Corp. · Gastroenterology & Urology device
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Mar 1991
Decision
151d
Days
Class 2
Risk

K904669 is an FDA 510(k) clearance for the BALLOON CATHETERS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on March 15, 1991 after a review of 151 days - an extended review 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: 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 Corp. devices

FDA 510(k) Submission Details - K904669

510(k) Number K904669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1990
Decision Date March 15, 1991
Days to Decision 151 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
20d slower than avg
Panel avg: 131d · This submission: 151d
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 411
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K904669.
BILIARY BALLOON DILATATION CATHETER
K910931 · Boston Scientific Corp · Apr 1991
AVD INTIMAX CHOLANGIOGRAPHY CATHETER
K910493 · Applied Vascular Devices, Inc. · Mar 1991
OPERATIVE CHOLANGIOGRAPHIC CATHETER
K905738 · Applied Vascular Devices, Inc. · Mar 1991
BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS
K905707 · Baxter Healthcare Corp · Feb 1991
ERCP CANNULA
K905714 · Everest Medical Corp. · Feb 1991
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS
K905229 · Arrow Intl., Inc. · Jan 1991