Cleared Traditional

CYSTIC DUCT BALLOON DILATING CATHETER (K983154) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983154 · Applied Medical Resources · Gastroenterology & Urology device
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May 1999
Decision
238d
Days
Class 2
Risk

K983154 is an FDA 510(k) clearance for the CYSTIC DUCT BALLOON DILATING CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on May 5, 1999 after a review of 238 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Applied Medical Resources devices

Submission Details

510(k) Number K983154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1998
Decision Date May 05, 1999
Days to Decision 238 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 130d · This submission: 238d
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 217
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K983154.
RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
K990867 · Advanced Cardiovascular Systems, Inc. · Sep 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS
K991674 · Cordis Corp. · Aug 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES
K991028 · Cordis Corp. · Aug 1999
CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC
K990631 · Cordis Corp. · Apr 1999
WILSON-COOK PANCREATIC WEDGE STENT
K990130 · Wilson-Cook Medical, Inc. · Feb 1999
CORDIS NITINOL STENT AND DELIVERY SYSTEM
K980823 · Cordis Corp. · Dec 1998