Cleared Traditional

K010107 - R STENT BILIARY ENDOPROSTHESIS

K010107 is an FDA 510(k) clearance for R STENT BILIARY ENDOPROSTHESIS, manufactured by Orbus Medical Technologies. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K010107 · Orbus Medical Technologies · Gastroenterology & Urology device
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Jul 2001
Decision
200d
Days
Class 2
Risk

K010107 is an FDA 510(k) clearance for the R STENT BILIARY ENDOPROSTHESIS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Orbus Medical Technologies (Fort Lauderdale, US). The FDA issued a Cleared decision on July 31, 2001 after a review of 200 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 Orbus Medical Technologies devices

FDA 510(k) Submission Details - K010107

510(k) Number K010107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received January 12, 2001
Decision Date July 31, 2001
Days to Decision 200 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
70d slower than avg
Panel avg: 130d · This submission: 200d
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 K010107.
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K012216 · Boston Scientific Scimed, Inc. · Aug 2001
COOK ZILVER BILIARY STENT
K010242 · Cook, Inc. · Aug 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012087 · Cordis Corp. · Aug 2001
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K011881 · Guidant Corp. · Jul 2001
OMNILINK .035 BILIARY STENT SYSTEM
K011506 · Guidant Corp. · Jun 2001
OMNILINK .018 BILIARY STENT SYSTEM
K011039 · Guidant Corp. · May 2001