Cleared Abbreviated

K021994 - BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM

K021994 is an FDA 510(k) clearance for BARD CONFORMEXX BILIARY STENT AND DELIV..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Abbreviated 510(k) pathway after a 198-day FDA review.

K021994 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
198d
Days
Class 2
Risk

K021994 is an FDA 510(k) clearance for the BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on January 2, 2003 after a review of 198 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K021994

510(k) Number K021994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received June 18, 2002
Decision Date January 02, 2003
Days to Decision 198 days
Submission Type Abbreviated
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
67d slower than avg
Panel avg: 131d · This submission: 198d
Pathway characteristics
Standards-based clearance path.

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 477
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K021994.
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
K023248 · Orbus Medical Technologies · Feb 2003
EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
K010714 · Medi-Globe Corp. · Jan 2003
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K024048 · Boston Scientific Scimed, Inc. · Jan 2003
FLEXIMA BILIARY CATHETER
K023870 · Boston Scientific/Medi-Tech · Dec 2002
VIABIL BILIARY ENDOPROSTHESIS
K014215 · W.L. Gore & Associates, Inc. · Dec 2002
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K023243 · Sulzer Intratherapeutics, Inc. · Dec 2002
K021994 · BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM
Download PDF FDA Summary C.R. Bard, Inc.