Cleared Traditional

LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS (K905229) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K905229 · Arrow Intl., Inc. · Gastroenterology & Urology device
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Jan 1991
Decision
59d
Days
Class 2
Risk

K905229 is an FDA 510(k) clearance for the LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 59 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 Arrow Intl., Inc. devices

Submission Details

510(k) Number K905229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date January 18, 1991
Days to Decision 59 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 130d · This submission: 59d
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 195
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K905229.
BILIARY BALLOON DILATATION CATHETER
K910931 · Boston Scientific Corp · Apr 1991
BALLOON CATHETERS
K904669 · Olympus Corp. · Mar 1991
BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS
K905707 · Baxter Healthcare Corp · Feb 1991
COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION
K903858 · Cook, Inc. · Oct 1990
PR CANNULAS
K902734 · Olympus Corp. · Aug 1990
BARD/ANGIOMED STENTS
K896391 · C.R. Bard, Inc. · Mar 1990