Cleared Traditional

BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR (K092144) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K092144 · Endochoice, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
222d
Days
Class 2
Risk

K092144 is an FDA 510(k) clearance for the BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE A.... Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Endochoice, Inc. (Chalotte, US). The FDA issued a Cleared decision on February 22, 2010 after a review of 222 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 Endochoice, Inc. devices

Submission Details

510(k) Number K092144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2009
Decision Date February 22, 2010
Days to Decision 222 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 130d · This submission: 222d
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 33
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K092144.
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K130004 · Boston Scientific Corporation · Dec 2013
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K120983 · Boston Scientific Corporation · May 2012
ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
K111611 · Merit Medical Systems, Inc. · Jul 2011
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K091816 · Boston Scientific Corporation · Jul 2009
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730
K091510 · Boston Scientific Corporation · Jun 2009
POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
K080332 · Boston Scientific Corporation · Sep 2008