Cleared Traditional

K181669 - ConvertX Biliary Stent System

K181669 is the FDA 510(k) clearance for ConvertX Biliary Stent System by Brightwater Medical. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K181669 · Brightwater Medical · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
262d
Days
Class 2
Risk

K181669 is an FDA 510(k) clearance for the ConvertX Biliary Stent System. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Brightwater Medical (Dunlap, US). The FDA issued a Cleared decision on March 14, 2019 after a review of 262 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 Brightwater Medical devices

Submission Details

510(k) Number K181669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2018
Decision Date March 14, 2019
Days to Decision 262 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 130d · This submission: 262d
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 298
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K181669.
BIOTEQ Drainage Catheter Set (One Step Type)
K200103 · Bioteque Corporation · Oct 2020
EndoGI S-Path Biliary Stent System
K202477 · Endo GI Medical · Sep 2020
EndoGI Biliary Stent System
K193600 · Endogi Medical, Ltd. · Jun 2020
HANAROSTENT FASTTM Biliary (NNN)
K183396 · M.I. Tech Co., Ltd. · Feb 2019
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
K182980 · Cook Ireland, Ltd. · Nov 2018
Reliant(TM) Multistage Dilatation Balloon Catheter
K180418 · Micro-Tech (Nanjing) Co., Ltd. · Oct 2018