Cleared Traditional

K945201 - COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT

K945201 is an FDA 510(k) clearance for COVERD GIANTURCO-ROSCH 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 71-day FDA review.

K945201 · Cook, Inc. · Gastroenterology & Urology device
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Jan 1995
Decision
71d
Days
Class 2
Risk

K945201 is an FDA 510(k) clearance for the COVERD GIANTURCO-ROSCH 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 January 4, 1995 after a review of 71 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 Cook, Inc. devices

FDA 510(k) Submission Details - K945201

510(k) Number K945201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1994
Decision Date January 04, 1995
Days to Decision 71 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
60d faster than avg
Panel avg: 131d · This submission: 71d
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 K945201.
MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM
K973584 · Medtech Instruments · Jan 1998
INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM
K955041 · Instent, Inc. · Feb 1996
ULTRAFLEX
K955347 · Boston Scientific Corp · Feb 1996
WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)
K940396 · Boston Scientific Scimed, Inc. · Oct 1994
WALLSTENT ESOPHAGEAL PROSTHESIS
K940395 · Boston Scientific Scimed, Inc. · Sep 1994
MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM
K940838 · Boston Scientific Corp · Aug 1994