Product code KNY

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
Accessories, Catheter, G-U
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)DeviceApplicantDecision date
K182144Bi-Flex EvoPromepla Sam2018-09-07
K162356Vesair Cystoscopic SheathSolace Therapeutics2017-03-02
K140441BI-FLEX URETERAL ACCESS SHEATHPromepla Sam2014-06-17
K140562WIJAY EZ-VOID EXTERNAL CATHETER VALVELeomed, LLC2014-06-16
K141252GUARDIAN URETHRAL SHEATHSolace Therapeutics2014-06-09
K131803GUARDIAN URETHRAL SHEATHSolace Therapeutics2013-08-20
K123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies America2013-02-04
K120160ROCAMED ROCAUS PLATINUMPromepla Sam2012-05-14
K112209PREFILLED CATHETER INFLATION SYRINGEAvail Medical Products, Inc.2011-09-08
K090121PRE-FILLED CATHETER INFLATION SYRINGEAvail Medical Products, Inc.2009-04-15
K052298CYSTOGLIDE INTRODUCER SHEATHPercutaneous Systems, Incorporated2006-12-12
K062240CAREVENTChief Medical, LLC2006-10-16
K052952CATHASSISTPhysician Technologies, Inc.2006-05-14
K052134CYSTOGLIDE DILATING INTRODUCER SHEATHPercutaneous Systems, Inc.2005-09-22
K051593UROPASS URETERAL ACCESS SHEATH, MODEL 61224Acmi Corporation2005-09-02
K042531UPDATED SLIP UROLOGY INTRODUCER SHEATHPercutaneous Systems, Incorporated2005-02-01
K042877MICROVERTER URETERAL ACCESS SHEATHPercutaneous Systems, Inc.2004-11-16
K040520SLIP UROLOGY INTRODUCER SHEATHPercutaneous Systems, Inc.2004-05-20
K032127HEMEDEX FIXATION DEVICEHemedex Incorporated2003-12-30
K023690CATHETER CONNECTORWorld Metals, Inc.2003-02-28
K000767MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201Memcath Technologies, LLC2000-06-05
K991097PBN DRAINAGE CATHETER GUIDEWIRESMedical Device Technologies, Inc.1999-04-23
K981611SNAP-N-PEEL INTRODUCERSCircon Corp.1998-07-30
K981667HYDROPHILIC COATED GUIDEWIRELake Region Mfg., Inc.1998-06-05
K981229MANAN MANTA CATHETER FIXATION DISKMedical Device Technologies, Inc.1998-04-22
K972977INSULATOR WIRE GUIDECook Urological, Inc.1997-10-10
K960866LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.Lake Region Mfg., Inc.1996-04-05
K954132MANAN MANTA CATHETER FIXATION DISKManan Medical Products, Inc.1996-03-26
K952414PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETERAcacia Laboratories, Inc.1995-06-23
K951995KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTORKarl Storz Endoskop GmbH1995-05-24

Related GUDID Devices

Primary DIBrandCompanyPublished
50192253027646DoverCardinal Health 200, LLC2024-07-10
10192253032338DoverCardinal Health 200, LLC2024-07-10
03700512986225Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cmPromepla2017-11-09
03700512986218Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cmPromepla2017-11-09
03700512986201Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cmPromepla2017-11-09
03700512986195Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cmPromepla2017-11-09
10680651445787HalyardAvanos Medical, Inc.2017-05-10
00821925035171UroPass Ureteral Access SheathGyrus Acmi, Inc.2016-10-03
00821925035164UroPass Ureteral Access SheathGyrus Acmi, Inc.2016-10-03
00821925035157UroPass Ureteral Access SheathGyrus Acmi, Inc.2016-10-03
03700512983613BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cmPromepla2016-10-03
03700512983606BI-FLEX ACCESS SHEATH - 10 inner / 12 outer - Length 45cmPromepla2016-10-03
03700512983590BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cmPromepla2016-10-03
20884521007816DoverCardinal Health, Inc.2016-09-24
04048551086025n.a.Karl Storz GmbH & Co. KG2016-09-23
03700512985594RocaFlex Access Sheath & Dilation Catheter 12/14x35cmPromepla2016-09-14
03700512985617RocaFlex Access Sheath & Dilation Catheter 12/14x45cmPromepla2016-09-14
03700512985600RocaFlex Access Sheath & Dilation Catheter 10/12x45cmPromepla2016-09-14
03700512985587RocaFlex Access Sheath & Dilation Catheter 10/12x35cmPromepla2016-09-14
10801741052504Bard® "C" ClampC. R. Bard, Inc.2016-08-25
10801741046244Bard® Large Nylon Catheter PlugC. R. Bard, Inc.2016-08-22
10801741046251Bard® Small Nylon Catheter PlugC. R. Bard, Inc.2016-08-22
03700512963585Bi-FlexPromepla2016-07-19
30607915123056 ACUCISE® CUSTOM KITAPPLIED MEDICAL RESOURCES CORPORATION2015-10-16
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20607915128122 ACUCISE® PROCEDURAL PACK UNIVERSAL PACK AAPPLIED MEDICAL RESOURCES CORPORATION2015-10-09
20607915128139 ACUCISE® PROCEDURAL PACK UNIVERSAL PACK BAPPLIED MEDICAL RESOURCES CORPORATION2015-10-09
20607915128146 ACUCISE® PROCEDURAL PACK UNIVERSAL PACK CAPPLIED MEDICAL RESOURCES CORPORATION2015-10-09
20607915128191 ACUCISE® PROCEDURAL PACK FEMALE PACK BAPPLIED MEDICAL RESOURCES CORPORATION2015-10-09