Cleared Traditional

K940396 - WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)

K940396 is the FDA 510(k) clearance for WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE) by Boston Scientific Scimed, Inc.. It is a Class 2 Gastroenterology & Urology device (product code ESW) cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K940396 · Boston Scientific Scimed, Inc. · Gastroenterology & Urology device
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Oct 1994
Decision
249d
Days
Class 2
Risk

K940396 is an FDA 510(k) clearance for the WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE). Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Boston Scientific Scimed, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 3, 1994 after a review of 249 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Scimed, Inc. devices

Submission Details

510(k) Number K940396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1994
Decision Date October 03, 1994
Days to Decision 249 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
119d slower than avg
Panel avg: 130d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K940396.
BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
K002094 · C.R. Bard, Inc. · Oct 2000
ULTRAFLEX
K955347 · Boston Scientific Corp · Feb 1996
COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT
K945201 · Cook, Inc. · Jan 1995
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