Cleared Abbreviated

K993392 - BARD MEMOTHERM FLEXX BILIARY STENT

K993392 is the FDA 510(k) clearance for BARD MEMOTHERM FLEXX BILIARY STENT by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K993392 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Jan 2000
Decision
90d
Days
Class 2
Risk

K993392 is an FDA 510(k) clearance for the BARD MEMOTHERM FLEXX BILIARY STENT. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on January 6, 2000 after a review of 90 days - within the typical 510(k) review window.

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.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K993392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received October 08, 1999
Decision Date January 06, 2000
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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 K993392.
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
K993303 · Boston Scientific Corp · Mar 2000
OTW MEGALINK SDS BILIARY STENT SYSTEM
K000550 · Advanced Cardiovascular Systems, Inc. · Mar 2000
MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B
K994156 · Cordis Corp. · Jan 2000
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
K993892 · C.R. Bard, Inc. · Jan 2000
WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K993232 · Boston Scientific Scimed, Inc. · Dec 1999
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K994068 · Cordis Corp. · Dec 1999