Cleared Special

BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM (K001258) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K001258 · Cordis Corp. · Gastroenterology & Urology device
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Jun 2000
Decision
70d
Days
Class 2
Risk

K001258 is an FDA 510(k) clearance for the BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cordis Corp. (Warren, US). The FDA issued a Cleared decision on June 27, 2000 after a review of 70 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cordis Corp. devices

Submission Details

510(k) Number K001258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 18, 2000
Decision Date June 27, 2000
Days to Decision 70 days
Submission Type Special
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
60d faster than avg
Panel avg: 130d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

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 213
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K001258.
NIR BILLIARY STENT SYSTEM
K002133 · Boston Scientific 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
WALLSTENT BILIARY ENDOPROSTHESIS
K000308 · Boston Scientific Corp · May 2000
CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
K000564 · Cordis Corp. · Mar 2000
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
K993303 · Boston Scientific Corp · Mar 2000