Cleared Traditional

K162226 - Reliant Multistage Dilatation Balloon C...

K162226 is the FDA 510(k) clearance for Reliant Multistage Dilatation Balloon C... by Micro-Tech (Nanjing) Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K162226 · Micro-Tech (Nanjing) Co., Ltd. · Gastroenterology & Urology device
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Jan 2017
Decision
170d
Days
Class 2
Risk

K162226 is an FDA 510(k) clearance for the Reliant Multistage Dilatation Balloon Catheter. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on January 25, 2017 after a review of 170 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 Micro-Tech (Nanjing) Co., Ltd. devices

Submission Details

510(k) Number K162226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2016
Decision Date January 25, 2017
Days to Decision 170 days
Submission Type Traditional
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
40d slower than avg
Panel avg: 130d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 269
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K162226.
Quantum TTC Biliary Balloon Dilator
K171223 · Wilson-Cook Medical, Inc. · Jun 2017
GORE VIABIL Short Wire Biliary Endoprosthesis
K170740 · W.L. Gore & Associates, Inc. · May 2017
AngioDynamics Total Abscession Biliary Drainage Catheter
K170743 · AngioDynamics, Inc. · Mar 2017
Express SD Biliary Monorail Premounted Stent System
K162404 · Boston Scientific Corporation · Oct 2016
Soehendra Stent Retriever
K161203 · Wilson-Cook Medical, Inc. · May 2016
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
K152853 · Boston Scientific Corp · Nov 2015