Cleared Traditional

K200260 - Percuflex Ureteral Stent System

K200260 is the FDA 510(k) clearance for Percuflex Ureteral Stent System by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 448-day FDA review.

K200260 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
448d
Days
Class 2
Risk

K200260 is an FDA 510(k) clearance for the Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percufl.... Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on April 26, 2021 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K200260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 03, 2020
Decision Date April 26, 2021
Days to Decision 448 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
318d slower than avg
Panel avg: 130d · This submission: 448d
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 K200260.
RELIEF Ureteral Stent Kit
K213444 · Ureteral Stent Company · Mar 2022
NovoFlow Reinforced Ureteral Stent
K213186 · Coloplast Corp. · Feb 2022
JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
K212868 · Rocamed Sam · Jan 2022
Vortek Single Loop Ureteral Stent
K201436 · Coloplast Corp. · Feb 2021
Ureteral Stent Systems, Biliary Drainage Catheters
K191446 · Boston Scientific Corporation · Jan 2020
Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip
K190659 · Allwin Medical Devices, Inc. · Dec 2019