Cleared Traditional

MANAN BILIARY DRAINAGE CATHETER (K954043) - FDA 510(k) Clearance

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

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

Submission Details

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
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 130d · This submission: 210d
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 188
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K954043.
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
K963397 · Boston Scientific Corp · Nov 1996
OLYMPUS B-5/B-7 SERIESBALLOON CATHETER
K962925 · Olympus America, Inc. · Oct 1996
CORDIS BILIARY STENT
K955728 · Cordis Corp. · May 1996
OLYMPUS NBD TUBES
K944912 · Olympus America, Inc. · Jun 1995
OLYMPUS PBD STENTS
K933200 · Olympus Corp. · Apr 1995
MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH
K930623 · Boston Scientific Corp · Sep 1994