Product code ESW— General, Plastic Surgery
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
- Classification name
- Prosthesis, Esophageal
- Device class
- Class 2
- Regulation
- 21 CFR 878.3610
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 60
- First cleared
- Most recent
Market context for product code ESW
FDA has cleared devices under product code ESW between 1987 and 2026, filed by 24 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2022
- 2021
- 2020
- 2019
- 2018
- 2016
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
Top applicants under product code ESW
Adverse events under product code ESW
product code ESW- Death
- 11
- Injury
- 353
- Malfunction
- 442
- Total
- 806
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code ESW
- K261978 — WallFlex Esophageal Stent System; Agile Esophageal Over-the-Wire (OTW) Stent System
- K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent
- K253327 — HANAROSTENT Esophagus Upper (CCC)
- K251265 — Resilience Fully Covered Esophageal Stent System
- K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
- K233837 — Agile Esophageal Stent System
- K240522 — Esophageal TTS Stent
- K223266 — Hilzo Esophageal Stents
- K221482 — Esophageal TTS Stent
- K211960 — Agile Esophageal OTW Stent System
- K213251 — HANAROSTENT Esophagus Asymmetric (CCC)
- K211706 — Esophageal TTS Stent
- K201160 — HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
- K200860 — HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
- K182910 — Segmented Esophageal Stent System
- K180144 — Agile Esophageal Stent System
- K172813 — Esophageal Stent System
- K162717 — Evolution Esophageal Stent System Partially Covered
- K130004 — ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
- K123205 — ESOPHAGEAL TTS STENT
- K120983 — ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
- K113551 — ESOPHAGEAL TTS STENT
- K111611 — ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
- K093619 — EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E
- K093537 — HANAROSTENT ESOPHAGUS (CCC)
- K092144 — BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR
- K091816 — ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
- K091510 — WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730
- K080782 — NITI-S ESOPHAGEAL STENT
- K072094 — CHOOSTENT
- K080332 — POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
- K080359 — EVOLUTION ESOPHAGEAL STENT SYSTEM
- K080838 — ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
- K073266 — WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
- K060239 — ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM
- K051621 — ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
- K041648 — NITI-S STENT & INTRODUCER, MODEL EOXXXX
- K032930 — ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
- K030559 — RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
- K011591 — ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
- K012883 — ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
- K003173 — ASPIRE COVERED STENT AND DELIVERY CATHETER
- K010068 — RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
- K002094 — BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
- K984068 — FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS
- K983297 — MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE
- K973584 — MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM
- K955041 — INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM
- K955347 — ULTRAFLEX
- K941487 — INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS
- K945201 — COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT
- K940396 — WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)
- K940395 — WALLSTENT ESOPHAGEAL PROSTHESIS
- K940838 — MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM
- K920218 — ESOPHAGEAL Z-STENT
- K923119 — WALLSTENT ESOPHAGEAL PROTHESIS
- K914029 — ESOPHAGEAL Z-STENT
- K904821 — ELIACHAR MODIFIED ESOPHAGEAL STENT
- K885309 — WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS
- K871244 — HOOD ESOPHAGEAL PROSTHESIS
Data sourced from openFDA. This site is unofficial and independent of the FDA.