Cleared Traditional

K914029 - ESOPHAGEAL Z-STENT

K914029 is an FDA 510(k) clearance for ESOPHAGEAL Z-STENT, manufactured by Cook, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code ESW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K914029 · Cook, Inc. · Gastroenterology & Urology device
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Dec 1991
Decision
90d
Days
Class 2
Risk

K914029 is an FDA 510(k) clearance for the ESOPHAGEAL Z-STENT. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 90 days - within the typical 510(k) review window.

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 Cook, Inc. devices

FDA 510(k) Submission Details - K914029

510(k) Number K914029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1991
Decision Date December 09, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 131d · This submission: 90d
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 52
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K914029.
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
ELIACHAR MODIFIED ESOPHAGEAL STENT
K904821 · Hood Laboratories · Jan 1991
WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS
K885309 · Wilson-Cook Medical, Inc. · Feb 1990
HOOD ESOPHAGEAL PROSTHESIS
K871244 · Hood Laboratories · Apr 1987