Cleared Traditional

K923119 - WALLSTENT ESOPHAGEAL PROTHESIS

K923119 is an FDA 510(k) clearance for WALLSTENT ESOPHAGEAL PROTHESIS, manufactured by Schneider U.S. Stent Div.. The device is a Class 2 Gastroenterology & Urology device with product code ESW cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K923119 · Schneider U.S. Stent Div. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
67d
Days
Class 2
Risk

K923119 is an FDA 510(k) clearance for the WALLSTENT ESOPHAGEAL PROTHESIS. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Schneider U.S. Stent Div. (Plymouth, US). The FDA issued a Cleared decision on September 1, 1992 after a review of 67 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 Schneider U.S. Stent Div. devices

FDA 510(k) Submission Details - K923119

510(k) Number K923119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1992
Decision Date September 01, 1992
Days to Decision 67 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
63d faster than avg
Panel avg: 130d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ESW Device Classification - Class 2, Special Controls

Product Code ESW Prosthesis, Esophageal
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 - ESW Prosthesis, Esophageal

All 42
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K923119.
WALLSTENT ESOPHAGEAL PROSTHESIS
K940395 · Boston Scientific Scimed, Inc. · Sep 1994
MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM
K940838 · Boston Scientific Corp · Aug 1994
ESOPHAGEAL Z-STENT
K920218 · Wilson-Cook Medical, Inc. · Feb 1994
ESOPHAGEAL Z-STENT
K914029 · Cook, Inc. · Dec 1991
WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS
K885309 · Wilson-Cook Medical, Inc. · Feb 1990