Cleared Traditional

K002235 - HORIZONS ERCP CANNULA

K002235 is an FDA 510(k) clearance for HORIZONS ERCP CANNULA, manufactured by Horizons Intl. Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K002235 · Horizons Intl. Corp. · Gastroenterology & Urology device
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Jan 2001
Decision
183d
Days
Class 2
Risk

K002235 is an FDA 510(k) clearance for the HORIZONS ERCP CANNULA. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Horizons Intl. Corp. (Aguadilla, US). The FDA issued a Cleared decision on January 23, 2001 after a review of 183 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 Horizons Intl. Corp. devices

FDA 510(k) Submission Details - K002235

510(k) Number K002235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2000
Decision Date January 23, 2001
Days to Decision 183 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
53d slower than avg
Panel avg: 130d · This submission: 183d
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 314
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K002235.
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K010445 · Cordis Corp. · Mar 2001
BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
K003186 · C.R. Bard, Inc. · Jan 2001
BARD LUMINEXX BILIARY STENT
K003793 · C.R. Bard, Inc. · Jan 2001
GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
K003753 · Uresil Corp. · Jan 2001