Cleared Traditional

K940838 - MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT ...

K940838 is the FDA 510(k) clearance for MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT ... by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code ESW) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K940838 · Boston Scientific Corp · Gastroenterology & Urology device
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Aug 1994
Decision
176d
Days
Class 2
Risk

K940838 is an FDA 510(k) clearance for the MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on August 18, 1994 after a review of 176 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 Corp devices

Submission Details

510(k) Number K940838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1994
Decision Date August 18, 1994
Days to Decision 176 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
46d slower than avg
Panel avg: 130d · This submission: 176d
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 K940838.
COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT
K945201 · Cook, Inc. · Jan 1995
WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)
K940396 · Boston Scientific Scimed, Inc. · Oct 1994
WALLSTENT ESOPHAGEAL PROSTHESIS
K940395 · Boston Scientific Scimed, Inc. · Sep 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