Cleared Special

K121832 - RESOLVE BILIARY LOCKING DRAINAGE CATHETER

K121832 is an FDA 510(k) clearance for RESOLVE BILIARY LOCKING DRAINAGE CATHETER, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 25-day FDA review.

K121832 · Merit Medical Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
25d
Days
Class 2
Risk

K121832 is an FDA 510(k) clearance for the RESOLVE BILIARY LOCKING DRAINAGE CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Angleton, US). The FDA issued a Cleared decision on July 17, 2012 after a review of 25 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 - K121832

510(k) Number K121832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2012
Decision Date July 17, 2012
Days to Decision 25 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
106d faster than avg
Panel avg: 131d · This submission: 25d
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 473
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K121832.
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K122546 · Idev Technologies, Inc. · Dec 2012
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE
K122072 · Boston Scientific Corporation · Sep 2012
SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K111627 · Idev Technologies, Inc. · Aug 2012
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
K121125 · Flexible Stenting Solutions, Inc. · Jul 2012
ARCHSTENT BILIARY SYSTEM
K113582 · Ostial Corporation · Jun 2012
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
K120452 · Flexible Stenting Solutions, Inc. · Apr 2012
K121832 · RESOLVE BILIARY LOCKING DRAINAGE CATHETER
Download PDF FDA Summary Merit Medical Systems…