Product code ESW

Product
Radiation Emitting Electronic Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical De
Definition
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Description
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; Var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
Regulation number
Radiation type
Radiation Emitting Electronic Product Codes // Qui
Applicable standards
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -

Current FDA Classification

Device name
Prosthesis, Esophageal
Medical specialty
General, Plastic Surgery
Device class
2
Regulation number
878.3610
Review panel
GU
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible

Related Records

Related 510(k) Records

510(k)DeviceApplicantDecision date
K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.2025-10-30
K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.2025-10-30
K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.2025-07-23
K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific2024-04-29
K233837Agile Esophageal Stent SystemBoston Scientific Corporation2024-04-04
K240522Esophageal TTS StentTaewoong Medical2024-03-22
K223266Hilzo Esophageal StentsThoracent, Inc.2024-01-16
K221482Esophageal TTS StentTaewoong Medical Co., Ltd.2022-06-22
K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation2021-11-22
K213251HANAROSTENT Esophagus Asymmetric (CCC)M.I.Tech Co., Ltd.2021-11-18
K211706Esophageal TTS StentTaewoong Medical Co., Ltd.2021-10-08
K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd.2021-07-23
K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd.2020-05-20
K182910Segmented Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.2019-05-29
K180144Agile Esophageal Stent SystemBoston Scientific Corporation2018-09-21
K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.2018-05-18
K162717Evolution Esophageal Stent System – Partially CoveredCook Ireland, Ltd.2016-12-21
K130004ULTRAFLEX ESOPHAGEAL NG STENT SYSTEMBoston Scientific Corporation2013-12-06
K123205ESOPHAGEAL TTS STENTTaewoong Medical Co., Ltd.2013-10-09
K120983ULTRAFLEX ESOPHAGEAL NG STENT SYSTEMBoston Scientific Corporation2012-05-02
K113551ESOPHAGEAL TTS STENTTaewoong Medical Co., Ltd.2012-02-14
K111611ENDOMAXX FULLY COVERED ESOPHAGEAL STENTMerit Medical Systems, Inc.2011-07-29
K093619EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-ECook Ireland, Ltd.2010-06-17
K093537HANAROSTENT ESOPHAGUS (CCC)M.I.Tech Co., Ltd.2010-06-04
K092144BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFREndochoice, Inc.2010-02-22
K091816ULTRAFLEX ESOPHAGEAL NG STENT SYSTEMBoston Scientific Corporation2009-07-01
K091510WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730Boston Scientific Corporation2009-06-26
K080782NITI-S ESOPHAGEAL STENTTaewoong Medical Co., Ltd.2009-01-30
K072094CHOOSTENTM.I.Tech Co., Ltd.2008-09-25
K080332POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330Boston Scientific Corporation2008-09-05

Related GUDID Devices

Primary DIBrandCompanyPublished
08800026631149HILZO Esophageal stentsBCM Co., Ltd.2026-01-29
00884450093580RESILIENCE™Merit Medical Systems, Inc.2026-01-24
00884450094242RESILIENCE™Merit Medical Systems, Inc.2026-01-24
00884450094105RESILIENCE™Merit Medical Systems, Inc.2026-01-24
00884450094037RESILIENCE™Merit Medical Systems, Inc.2026-01-24
00884450094020RESILIENCE™Merit Medical Systems, Inc.2026-01-24
00884450093917RESILIENCE™Merit Medical Systems, Inc.2026-01-24
00884450093627RESILIENCE™Merit Medical Systems, Inc.2026-01-24
00884450093603RESILIENCE™Merit Medical Systems, Inc.2026-01-24
00884450093597RESILIENCE™Merit Medical Systems, Inc.2026-01-24
08800026631989HILZO Esophageal stents BCM Co., Ltd.2026-01-22
08800026631293HILZO Esophageal stentsBCM Co., Ltd.2026-01-22
08800026631286HILZO Esophageal stentsBCM Co., Ltd.2026-01-22
08800026631231HILZO Esophageal stentsBCM Co., Ltd.2026-01-22
08800026631224HILZO Esophageal stentsBCM Co., Ltd.2026-01-22
08800026631217HILZO Esophageal stentsBCM Co., Ltd.2026-01-22
08800026631200HILZO Esophageal stentsBCM Co., Ltd.2026-01-22
08800026631194HILZO Esophageal stentsBCM Co., Ltd.2026-01-22
08800026631187HILZO Esophageal stentsBCM Co., Ltd.2026-01-22
08800026631170HILZO Esophageal stentsBCM Co., Ltd.2026-01-22
08800026631163HILZO Esophageal stentsBCM Co., Ltd.2026-01-22
08800026631156HILZO Esophageal stentsBCM Co., Ltd.2026-01-22
08800026612780HILZO Esophageal stents BCM Co., Ltd.2026-01-22
08800026612773HILZO Esophageal stents BCM Co., Ltd.2026-01-22
08800026612766HILZO Esophageal stents BCM Co., Ltd.2026-01-22
08800026612759HILZO Esophageal stents BCM Co., Ltd.2026-01-22
08800026612742HILZO Esophageal stents BCM Co., Ltd.2026-01-22
08800026612735HILZO Esophageal stents BCM Co., Ltd.2026-01-22
08800026612728HILZO Esophageal stents BCM Co., Ltd.2026-01-22
08800026612711HILZO Esophageal stents BCM Co., Ltd.2026-01-22