Cleared Special

K262913 - Protégé™ EverFlex™ Self-expanding Peripheral Stent System

K262913 is an FDA 510(k) clearance for Protégé EverFlex Self-expanding Periphe..., manufactured by Medtronic, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 29-day FDA review.

K262913 · Medtronic, Inc. · Gastroenterology & Urology device
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Sep 2026
Decision
29d
Days
Class 2
Risk

K262913 is an FDA 510(k) clearance for the Protégé™ EverFlex™ Self-expanding Peripheral Stent System. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Medtronic, Inc. (Plymouth, US). The FDA issued a Cleared decision on September 17, 2026 after a review of 29 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.

View all Medtronic, Inc. devices

FDA 510(k) Submission Details - K262913

510(k) Number K262913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2026
Decision Date September 17, 2026
Days to Decision 29 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
102d faster than avg
Panel avg: 131d · This submission: 29d
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 438
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K262913.
Drainage Catheter
K254179 · Canyon Medical, Inc. · Sep 2026
ARCHIMEDES Biodegradable Stent (Medium)
K260835 · Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · Jul 2026
Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019
K253393 · Hangzhou AGS MedTech Co., Ltd. · Jun 2026
Dilation Balloon Catheter
K253832 · Mirco-Tech (Nanjing) Co., Ltd. · Apr 2026
Endoflux™ Biliary & Pancreatic Stent Sets
K251658 · Medi-Globe GmbH · Apr 2026
BARE Wireguided Balloon Dilation Catheter (1235)
K253987 · GIE Medical · Mar 2026