Cleared Traditional

K980113 - WALLSTENT ENTERAL ENDOPROSTHESIS

K980113 is the FDA 510(k) clearance for WALLSTENT ENTERAL ENDOPROSTHESIS by Boston Scientific Scimed, Inc.. It is a Class 2 Gastroenterology & Urology device (product code MUM) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K980113 · Boston Scientific Scimed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
80d
Days
Class 2
Risk

K980113 is an FDA 510(k) clearance for the WALLSTENT ENTERAL ENDOPROSTHESIS. Classified as Stent, Metallic, Expandable, Duodenal (product code MUM), Class II - Special Controls.

Submitted by Boston Scientific Scimed, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 3, 1998 after a review of 80 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 Scimed, Inc. devices

Submission Details

510(k) Number K980113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1998
Decision Date April 03, 1998
Days to Decision 80 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: 130d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K980113.
Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
K250663 · Taewoong Medical Co., Ltd. · Mar 2025
Niti-S Duodenal Stent
K223067 · Taewoong Medical Co., Ltd. · Jun 2023
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
K062750 · Boston Scientific Corp · Dec 2006