Cleared Traditional

K954043 - MANAN BILIARY DRAINAGE CATHETER

K954043 is an FDA 510(k) clearance for MANAN BILIARY DRAINAGE CATHETER, manufactured by Manan Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K954043 · Manan Medical Products, Inc. · Gastroenterology & Urology device
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Mar 1996
Decision
210d
Days
Class 2
Risk

K954043 is an FDA 510(k) clearance for the MANAN BILIARY DRAINAGE CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on March 26, 1996 after a review of 210 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 Manan Medical Products, Inc. devices

FDA 510(k) Submission Details - K954043

510(k) Number K954043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1995
Decision Date March 26, 1996
Days to Decision 210 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
79d slower than avg
Panel avg: 131d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 411
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K954043.
LMI BILIARY CATHETER
K955126 · Lucas Medical, Inc. · May 1996
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS
K961262 · Boston Scientific Scimed, Inc. · May 1996
CORDIS BILIARY STENT
K955728 · Cordis Corp. · May 1996
ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER
K955413 · Endovations · Feb 1996
MS CLASSIQUE BALLOON DILATATION CAHTETER
K953332 · Meadox Medicals, Div. Boston Scientific Corp. · Oct 1995
GIP/MEDI-GLOBE ERCP CATHETERS
K953827 · Medi-Globe Corp. · Sep 1995