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) | Device | Applicant | Decision date |
|---|---|---|---|
| K253327 | HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. | 2025-10-30 |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2025-10-30 |
| K251265 | Resilience Fully Covered Esophageal Stent System | Merit Medical Systems, Inc. | 2025-07-23 |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Boston Scientific | 2024-04-29 |
| K233837 | Agile Esophageal Stent System | Boston Scientific Corporation | 2024-04-04 |
| K240522 | Esophageal TTS Stent | Taewoong Medical | 2024-03-22 |
| K223266 | Hilzo Esophageal Stents | Thoracent, Inc. | 2024-01-16 |
| K221482 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2022-06-22 |
| K211960 | Agile Esophageal OTW Stent System | Boston Scientific Corporation | 2021-11-22 |
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | M.I.Tech Co., Ltd. | 2021-11-18 |
| K211706 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2021-10-08 |
| K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | M.I.Tech Co., Ltd. | 2021-07-23 |
| K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) | M.I.Tech Co., Ltd. | 2020-05-20 |
| K182910 | Segmented Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2019-05-29 |
| K180144 | Agile Esophageal Stent System | Boston Scientific Corporation | 2018-09-21 |
| K172813 | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2018-05-18 |
| K162717 | Evolution Esophageal Stent System Partially Covered | Cook Ireland, Ltd. | 2016-12-21 |
| K130004 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | 2013-12-06 |
| K123205 | ESOPHAGEAL TTS STENT | Taewoong Medical Co., Ltd. | 2013-10-09 |
| K120983 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | 2012-05-02 |
| K113551 | ESOPHAGEAL TTS STENT | Taewoong Medical Co., Ltd. | 2012-02-14 |
| K111611 | ENDOMAXX FULLY COVERED ESOPHAGEAL STENT | Merit Medical Systems, Inc. | 2011-07-29 |
| 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 | Cook Ireland, Ltd. | 2010-06-17 |
| K093537 | HANAROSTENT ESOPHAGUS (CCC) | M.I.Tech Co., Ltd. | 2010-06-04 |
| K092144 | BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR | Endochoice, Inc. | 2010-02-22 |
| K091816 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | 2009-07-01 |
| K091510 | WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 | Boston Scientific Corporation | 2009-06-26 |
| K080782 | NITI-S ESOPHAGEAL STENT | Taewoong Medical Co., Ltd. | 2009-01-30 |
| K072094 | CHOOSTENT | M.I.Tech Co., Ltd. | 2008-09-25 |
| K080332 | POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 | Boston Scientific Corporation | 2008-09-05 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800026631149 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-29 |
| 00884450093580 | RESILIENCE™ | Merit Medical Systems, Inc. | 2026-01-24 |
| 00884450094242 | RESILIENCE™ | Merit Medical Systems, Inc. | 2026-01-24 |
| 00884450094105 | RESILIENCE™ | Merit Medical Systems, Inc. | 2026-01-24 |
| 00884450094037 | RESILIENCE™ | Merit Medical Systems, Inc. | 2026-01-24 |
| 00884450094020 | RESILIENCE™ | Merit Medical Systems, Inc. | 2026-01-24 |
| 00884450093917 | RESILIENCE™ | Merit Medical Systems, Inc. | 2026-01-24 |
| 00884450093627 | RESILIENCE™ | Merit Medical Systems, Inc. | 2026-01-24 |
| 00884450093603 | RESILIENCE™ | Merit Medical Systems, Inc. | 2026-01-24 |
| 00884450093597 | RESILIENCE™ | Merit Medical Systems, Inc. | 2026-01-24 |
| 08800026631989 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026631293 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026631286 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026631231 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026631224 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026631217 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026631200 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026631194 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026631187 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026631170 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026631163 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026631156 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026612780 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026612773 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026612766 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026612759 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026612742 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026612735 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026612728 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |
| 08800026612711 | HILZO Esophageal stents | BCM Co., Ltd. | 2026-01-22 |