Cleared Special

K012216 - NIROYAL BILIARY PREMOUNTED STENT SYSTEM

K012216 is an FDA 510(k) clearance for NIROYAL BILIARY PREMOUNTED STENT SYSTEM, manufactured by Boston Scientific Scimed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 32-day FDA review.

K012216 · Boston Scientific Scimed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
32d
Days
Class 2
Risk

K012216 is an FDA 510(k) clearance for the NIROYAL BILIARY PREMOUNTED STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific Scimed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on August 17, 2001 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K012216

510(k) Number K012216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received July 16, 2001
Decision Date August 17, 2001
Days to Decision 32 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 131d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

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 477
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K012216.
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
K010411 · Cordis Corp. · Aug 2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K012347 · Sulzer Intratherapeutics, Inc. · Aug 2001
BRIDGE FX
K011817 · Medtronic Ave, Inc. · Aug 2001
COOK ZILVER BILIARY STENT
K010242 · Cook, Inc. · Aug 2001
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
K011184 · Intratherapeutics, Inc. · Aug 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K012056 · Cordis Europa, N.V. · Aug 2001
K012216 · NIROYAL BILIARY PREMOUNTED STENT SYSTEM
Download PDF FDA Summary Boston Scientific Sci…