Cleared Traditional

K161277 - ConvertX Nephroureteral Stent System

K161277 is the FDA 510(k) clearance for ConvertX Nephroureteral Stent System by Brightwater Medical. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K161277 · Brightwater Medical · Gastroenterology & Urology device
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Nov 2016
Decision
200d
Days
Class 2
Risk

K161277 is an FDA 510(k) clearance for the ConvertX Nephroureteral Stent System. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Brightwater Medical (Dunlap, US). The FDA issued a Cleared decision on November 22, 2016 after a review of 200 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4620 - 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 K161277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2016
Decision Date November 22, 2016
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.

Device Classification

Product Code FAD Stent, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4620
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 - FAD Stent, Ureteral

All 75
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K161277.
Kwart Retro-Inject Ureteral Stent
K162109 · Cook Incorporated · Jun 2017
C-Flex Ureteral Stent Set
K162104 · Cook Incorporated · Apr 2017
Universa Firm Ureteral Stents and Stent Sets
K161236 · Cook Incorporated · Jan 2017
Ultrathane Endoureterotomy Stent Set
K160891 · Cook Incorporated · Jun 2016
Universa Soft Ureteral Stents and Stent Sets
K151051 · Cook Incorporated · Jan 2016
EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
K141344 · Boston Scientific Corp · Oct 2014