Cleared Traditional

K062264 - COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062264 · Medtronic Vascular · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
461d
Days
Class 2
Risk

K062264 is an FDA 510(k) clearance for the COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Medtronic Vascular (Santa Rosa, US). The FDA issued a Cleared decision on November 8, 2007 after a review of 461 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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: 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 Medtronic Vascular devices

Submission Details

510(k) Number K062264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 04, 2006
Decision Date November 08, 2007
Days to Decision 461 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
331d slower than avg
Panel avg: 130d · This submission: 461d
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 473
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K062264.
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
Single use stone retrieval balloons
K253132 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 2026
Niti-S Biliary Stent
K251123 · Taewoong Medical Co., Ltd. · Dec 2025
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
K251019 · Bioteque Corporation · Dec 2025