Cleared Special

K120983 - ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

K120983 is an FDA 510(k) clearance for ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM, manufactured by Boston Scientific Corporation. The device is a Class 2 Gastroenterology & Urology device with product code ESW cleared through the Special 510(k) pathway after a 30-day FDA review.

K120983 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
30d
Days
Class 2
Risk

K120983 is an FDA 510(k) clearance for the ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on May 2, 2012 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K120983

510(k) Number K120983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2012
Decision Date May 02, 2012
Days to Decision 30 days
Submission Type Special
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
101d faster than avg
Panel avg: 131d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 59
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K120983.
Evolution Esophageal Stent System – Partially Covered
K162717 · Cook Ireland, Ltd. · Dec 2016
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K130004 · Boston Scientific Corporation · Dec 2013
ESOPHAGEAL TTS STENT
K123205 · Taewoong Medical Co., Ltd. · Oct 2013
ESOPHAGEAL TTS STENT
K113551 · Taewoong Medical Co., Ltd. · Feb 2012
ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
K111611 · Merit Medical Systems, Inc. · Jul 2011
EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E
K093619 · Cook Ireland, Ltd. · Jun 2010
K120983 · ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
Download PDF FDA Summary Boston Scientific Cor…