Cleared Traditional

K002101 - ANGIODYNAMICS ABSCESSION BILIARY DRAINA...

K002101 is the FDA 510(k) clearance for ANGIODYNAMICS ABSCESSION BILIARY DRAINA... by AngioDynamics, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K002101 · AngioDynamics, Inc. · Gastroenterology & Urology device
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Jul 2000
Decision
49d
Days
Class 2
Risk

K002101 is an FDA 510(k) clearance for the ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on July 31, 2000 after a review of 49 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 AngioDynamics, Inc. devices

Submission Details

510(k) Number K002101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2000
Decision Date July 31, 2000
Days to Decision 49 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 130d · This submission: 49d
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 K002101.
NIR BILLIARY STENT SYSTEM
K002133 · Boston Scientific Corp · Oct 2000
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
K002143 · Guidant Corp. · Oct 2000
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
K001338 · Boston Scientific Corp · Aug 2000
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K001843 · Cordis Corp. · Jul 2000
BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
K001258 · Cordis Corp. · Jun 2000
WALLSTENT BILIARY ENDOPROSTHESIS
K000308 · Boston Scientific Corp · May 2000