Product code EZL
- 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
- Catheter, Retention Type, Balloon
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5130
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
Related Records
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252537 | Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. | 2026-01-20 |
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter) | Guangdong Ecan Medical Co., Ltd. | 2025-06-16 |
| K241424 | InnoCare Specialty Foley Catheter | Innocare Urologics, LLC | 2024-09-18 |
| K232469 | Rüsch Latex Gold Foley Catheter | Teleflexmedical, Inc. | 2024-08-01 |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC | 2024-04-17 |
| K233411 | Folysil Silicone Catheter | Coloplast Corp. | 2024-04-15 |
| K233013 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies Corporation | 2024-01-23 |
| K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | 2023-07-27 |
| K231101 | Flume Catheter | Flume Catheter Company, Ltd. | 2023-06-29 |
| K221020 | Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F | Potrero Medical, Inc. | 2023-01-13 |
| K222118 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies, Corp. | 2022-12-01 |
| K221625 | 2-Way 100% Silicone ClearTract Catheter | Silq Technologies Corporation | 2022-07-01 |
| K212151 | FLUME catheter | The Flume Catheter Company, Ltd. | 2021-11-03 |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co., Ltd. | 2021-04-08 |
| K201776 | Foley Balloon Catheter for Urology | Apollon Co., Ltd. | 2020-12-30 |
| K202698 | Prefilled Syringe | Hangzhou Primecare Medical Co., Ltd. | 2020-12-15 |
| K192034 | HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc | Pathway, LLC | 2020-04-21 |
| K200556 | AquaFlate Pre-Filled Sterile Water Syringe 10mL | H R Pharmaceuticals, Inc. | 2020-03-31 |
| K182463 | Silicone Foley Catheter | Biosensors International Pte, Ltd. | 2019-11-06 |
| K190060 | Urethrotech UCD | Urethrotech | 2019-10-04 |
| K182635 | Signal Catheter | Safe Medical Design | 2019-01-10 |
| K181616 | PSM 3-Way Silicone Foley Catheter | Pathway, LLC | 2018-09-21 |
| K180781 | Bard Vertus Foley Catheter | C.R. Bard, Inc. | 2018-09-19 |
| K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water | Amsino International, Inc. | 2018-09-04 |
| K173657 | Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter | Cook Incorporated | 2018-08-23 |
| K181346 | CystoSure Plus Catheter | Emmy Medical, LLC | 2018-08-06 |
| K173340 | Yikang Latex Foley Catheter | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2018-07-13 |
| K172807 | Silicone Foley Catheter for single use | Changzhou Rongxin Medicine Minimal Invasion Technology | 2018-06-04 |
| K173533 | Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter | Poiesis Medical, LLC | 2018-03-29 |
| K172422 | Kohli Urinary Drainage Catheter | Nellie Medical, LLC | 2018-02-09 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 50192253068236 | Dover | Cardinal Health 200, LLC | 2026-01-15 |
| 50192253068229 | Dover | Cardinal Health 200, LLC | 2026-01-15 |
| 50192253067659 | Dover | Cardinal Health 200, LLC | 2025-04-14 |
| 20192253067665 | Dover | Cardinal Health 200, LLC | 2025-04-14 |
| 50192253067673 | Dover | Cardinal Health 200, LLC | 2025-04-14 |
| 20192253067689 | Dover | Cardinal Health 200, LLC | 2025-04-14 |
| 10884522000031 | Covidien AG | DEGANIA SILICONE LTD | 2025-04-03 |
| 10884522000062 | Covidien AG | DEGANIA SILICONE LTD | 2025-04-03 |
| 10884522000055 | Covidien AG | DEGANIA SILICONE LTD | 2025-04-03 |
| 10884522000048 | Covidien AG | DEGANIA SILICONE LTD | 2025-04-03 |
| 10884522000024 | Covidien AG | DEGANIA SILICONE LTD | 2025-04-03 |
| 20884522000014 | Covidien AG | DEGANIA SILICONE LTD | 2025-04-03 |
| 00850029182016 | Egress Safety Catheter | InnoCare Urologics, LLC | 2025-03-19 |
| 27290110066516 | Covidien AG | DEGANIA SILICONE LTD | 2025-03-04 |
| 27290110066486 | Covidien AG | DEGANIA SILICONE LTD | 2025-02-20 |
| 27290110066523 | Covidien AG | DEGANIA SILICONE LTD | 2025-02-20 |
| 27290110066509 | Covidien AG | DEGANIA SILICONE LTD | 2025-02-20 |
| 27290110066493 | Covidien AG | DEGANIA SILICONE LTD | 2025-02-20 |
| 27290110066479 | Covidien AG | DEGANIA SILICONE LTD | 2025-02-20 |
| 16936881165051 | All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co.,Ltd | 2025-02-05 |
| 16944932785653 | All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co.,Ltd | 2025-02-05 |
| 16944932785684 | All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co.,Ltd | 2025-02-05 |
| 16944932785714 | All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co.,Ltd | 2025-02-05 |
| 16944932785752 | All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co.,Ltd | 2025-02-05 |
| 16944932785790 | All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co.,Ltd | 2025-02-05 |
| 16944932785820 | All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co.,Ltd | 2025-02-05 |
| 16944932785844 | All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co.,Ltd | 2025-02-05 |
| 16944932785875 | All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co.,Ltd | 2025-02-05 |
| 16944932785882 | All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co.,Ltd | 2025-02-05 |
| 16944932785912 | All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co.,Ltd | 2025-02-05 |