Cleared Traditional

K855142 - ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOL...

K855142 is the FDA 510(k) clearance for ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOL... by Angiomed U.S., Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K855142 · Angiomed U.S., Inc. · Gastroenterology & Urology device
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Mar 1986
Decision
75d
Days
Class 2
Risk

K855142 is an FDA 510(k) clearance for the ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Angiomed U.S., Inc. (Anaheim, US). The FDA issued a Cleared decision on March 11, 1986 after a review of 75 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 Angiomed U.S., Inc. devices

Submission Details

510(k) Number K855142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date March 11, 1986
Days to Decision 75 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
55d faster than avg
Panel avg: 130d · This submission: 75d
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 306
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K855142.
BILIARY BALLOON CATHETER
K863571 · Uresil Corp. · Nov 1986
BARD BALLOON DILATATION SYSTEM
K863437 · C.R. Bard, Inc. · Oct 1986
ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY
K860990 · Endovations · May 1986
PVL-4.8-200 BALLOON STONE EXTRACTOR
K851954 · Wilson-Cook Medical, Inc. · Dec 1985
ZIMMON BILIARY STENT SET
K851962 · Wilson-Cook Medical, Inc. · Dec 1985
ENDODYNAMICS SIEGEL THERAPUTIC STENT
K853666 · E-Z-Em, Inc. · Nov 1985