Cleared Traditional

K002094 - BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE

K002094 is an FDA 510(k) clearance for BARD MEMOTHERM COVERED ESOPHAGEAL STENT, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code ESW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K002094 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
87d
Days
Class 2
Risk

K002094 is an FDA 510(k) clearance for the BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on October 6, 2000 after a review of 87 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K002094

510(k) Number K002094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2000
Decision Date October 06, 2000
Days to Decision 87 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
44d faster than avg
Panel avg: 131d · This submission: 87d
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 51
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K002094.
ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
K011591 · Wilson-Cook Medical, Inc. · Jul 2002
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
K012883 · Boston Scientific Corp · Oct 2001
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
K010068 · Rusch Intl. · Feb 2001
FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS
K984068 · Schneider (Europe) GmbH · Jan 1999
MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE
K983297 · Medtronic Instent, Inc. · Dec 1998
MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM
K973584 · Medtech Instruments · Jan 1998