Product code KNS
- 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
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.4300
- 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 |
|---|---|---|---|
| K252388 | Vanquish Water Vapor Ablation Device | Francis Medical, Inc. | 2025-11-26 |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corporation | 2025-11-25 |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | Olympus Medical Systems Corp. | 2025-10-17 |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) | Olympus Medical Systems Corporation | 2025-10-10 |
| K251104 | SureTome SW Sphincterotome with DomeTip | Wilson-Cook Medical | 2025-09-29 |
| K251226 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | 2025-08-08 |
| K250584 | Rezum System | Boston Scientific Corporation | 2025-06-11 |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) | Creo Medical, Ltd. | 2025-06-06 |
| K241855 | SB Knife Jr2 (MD-47702 and MD-47702L) | Sb-Kawasumi Laboratories, Inc. | 2025-03-26 |
| K242192 | Disposable Sphincterotome | Beijing Zksk Technology Co., Ltd. | 2025-02-06 |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical, Inc. | 2025-01-17 |
| K241271 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | 2024-12-12 |
| K242061 | Reusable Interface Cable 1.5 m (PRD-IFC-002) | Creo Medical, Ltd. | 2024-08-15 |
| K232825 | Disposable Sphincterotome | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024-03-29 |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific | 2023-11-28 |
| K232476 | Disposable Sphincterotome | Zhejiang Soudon Medical Technology Co., Ltd. | 2023-11-07 |
| K230328 | Speedboat Flush SB1 Instrument | Creo Medical, Ltd. | 2023-10-31 |
| K233318 | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) | Boston Scientific Corporation | 2023-10-27 |
| K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) | Starmed Co., Ltd. | 2023-10-25 |
| K232162 | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome | Boston Scientific Corporation | 2023-08-14 |
| K231533 | Habib EndoHPB | Boston Scientific Corporation | 2023-06-21 |
| K222421 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2023-05-03 |
| K223256 | Optimos Cystotome | Taewoong Medical Co., Ltd. | 2023-04-05 |
| K222542 | MCB UNIT Model: V10GMCBUS | Lamidey Noury Medical | 2022-09-21 |
| K211909 | Cysto-Gastro-Sets | G-Flex Europe Sprl | 2022-06-09 |
| K212999 | Multi-Functional Electrosurgical Knife | Anrei Medical (Hangzhou) Co., Ltd. | 2022-03-21 |
| K213627 | RF Vapor System | Aqua Medical, Inc. | 2021-12-17 |
| K210934 | Sphincterotome / short-wire compatible, Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-01 |
| K211282 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2021-05-27 |
| K201121 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2021-02-05 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 16932503512227 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-08 |
| 16932503512210 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503513200 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503513194 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503513187 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512418 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512401 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512395 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512388 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512371 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512364 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512357 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512340 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512326 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512234 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512241 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512258 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512265 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512272 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512289 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512296 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512302 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512319 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 16932503512333 | Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2026-01-07 |
| 14953170466349 | Single Use 3-Lumen Needle Knife V | OLYMPUS MEDICAL SYSTEMS CORP. | 2025-12-18 |
| 14953170466356 | Single Use 3-Lumen Needle Knife V | OLYMPUS MEDICAL SYSTEMS CORP. | 2025-12-18 |
| 00827002613508 | SureTome SW | COOK INCORPORATED | 2025-12-08 |
| 10827002613512 | SureTome SW | COOK INCORPORATED | 2025-12-08 |
| 10827002613529 | SureTome SW | COOK INCORPORATED | 2025-12-08 |
| 00827002607842 | COOK | COOK INCORPORATED | 2025-07-22 |