Cleared Traditional

K062750 - WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030

K062750 is an FDA 510(k) clearance for WALLFLEX ENTERAL DUODENAL STENT WITH AN..., manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code MUM cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K062750 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
81d
Days
Class 2
Risk

K062750 is an FDA 510(k) clearance for the WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M005.... Classified as Stent, Metallic, Expandable, Duodenal (product code MUM), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlborough, US). The FDA issued a Cleared decision on December 4, 2006 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3610 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K062750

510(k) Number K062750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2006
Decision Date December 04, 2006
Days to Decision 81 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
50d faster than avg
Panel avg: 131d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUM Device Classification - Class 2, Special Controls

Product Code MUM Stent, Metallic, Expandable, Duodenal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3610
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 - MUM Stent, Metallic, Expandable, Duodenal

Devices cleared under the same product code (MUM) and FDA review panel - the closest regulatory comparables to K062750.
Niti-S Duodenal Stent
K223067 · Taewoong Medical Co., Ltd. · Jun 2023
Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
K163468 · Cook Ireland, Ltd. · May 2017
EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D
K101530 · Cook Ireland, Ltd. · Mar 2011
WALLSTENT ENTERAL ENDOPROSTHESIS
K980113 · Boston Scientific Scimed, Inc. · Apr 1998