Cleared Traditional

K943143 - BILIARY STENT

K943143 is an FDA 510(k) clearance for BILIARY STENT, manufactured by Menlo Care, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K943143 · Menlo Care, Inc. · Gastroenterology & Urology device
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Feb 1995
Decision
243d
Days
Class 2
Risk

K943143 is an FDA 510(k) clearance for the BILIARY STENT. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Menlo Care, Inc. (Menlo Park, US). The FDA issued a Cleared decision on February 28, 1995 after a review of 243 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 Menlo Care, Inc. devices

FDA 510(k) Submission Details - K943143

510(k) Number K943143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1994
Decision Date February 28, 1995
Days to Decision 243 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
112d slower than avg
Panel avg: 131d · This submission: 243d
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 404
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K943143.
OLYMPUS PBD STENTS
K933200 · Olympus Corp. · Apr 1995
MS CLASSIQUE BALLOON CATHETER
K944143 · Meadox Surgimed, Inc. · Mar 1995
WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER
K941350 · Wilson-Cook Medical, Inc. · Mar 1995
BALLOON DILATION CATHETER
K935094 · Wilson-Cook Medical, Inc. · Jan 1995
BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM
K925406 · Schneider Intl., Ltd. · Jan 1995
MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH
K930623 · Boston Scientific Corp · Sep 1994