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) | Device | Applicant | Decision date |
|---|---|---|---|
| K182144 | Bi-Flex Evo | Promepla Sam | 2018-09-07 |
| K162356 | Vesair Cystoscopic Sheath | Solace Therapeutics | 2017-03-02 |
| K140441 | BI-FLEX URETERAL ACCESS SHEATH | Promepla Sam | 2014-06-17 |
| K140562 | WIJAY EZ-VOID EXTERNAL CATHETER VALVE | Leomed, LLC | 2014-06-16 |
| K141252 | GUARDIAN URETHRAL SHEATH | Solace Therapeutics | 2014-06-09 |
| K131803 | GUARDIAN URETHRAL SHEATH | Solace Therapeutics | 2013-08-20 |
| K123170 | VARI-PASS VARIABLE LENGTH ACCESS SHEATH | Olympus Surgical Technologies America | 2013-02-04 |
| K120160 | ROCAMED ROCAUS PLATINUM | Promepla Sam | 2012-05-14 |
| K112209 | PREFILLED CATHETER INFLATION SYRINGE | Avail Medical Products, Inc. | 2011-09-08 |
| K090121 | PRE-FILLED CATHETER INFLATION SYRINGE | Avail Medical Products, Inc. | 2009-04-15 |
| K052298 | CYSTOGLIDE INTRODUCER SHEATH | Percutaneous Systems, Incorporated | 2006-12-12 |
| K062240 | CAREVENT | Chief Medical, LLC | 2006-10-16 |
| K052952 | CATHASSIST | Physician Technologies, Inc. | 2006-05-14 |
| K052134 | CYSTOGLIDE DILATING INTRODUCER SHEATH | Percutaneous Systems, Inc. | 2005-09-22 |
| K051593 | UROPASS URETERAL ACCESS SHEATH, MODEL 61224 | Acmi Corporation | 2005-09-02 |
| K042531 | UPDATED SLIP UROLOGY INTRODUCER SHEATH | Percutaneous Systems, Incorporated | 2005-02-01 |
| K042877 | MICROVERTER URETERAL ACCESS SHEATH | Percutaneous Systems, Inc. | 2004-11-16 |
| K040520 | SLIP UROLOGY INTRODUCER SHEATH | Percutaneous Systems, Inc. | 2004-05-20 |
| K032127 | HEMEDEX FIXATION DEVICE | Hemedex Incorporated | 2003-12-30 |
| K023690 | CATHETER CONNECTOR | World Metals, Inc. | 2003-02-28 |
| K000767 | MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 | Memcath Technologies, LLC | 2000-06-05 |
| K991097 | PBN DRAINAGE CATHETER GUIDEWIRES | Medical Device Technologies, Inc. | 1999-04-23 |
| K981611 | SNAP-N-PEEL INTRODUCERS | Circon Corp. | 1998-07-30 |
| K981667 | HYDROPHILIC COATED GUIDEWIRE | Lake Region Mfg., Inc. | 1998-06-05 |
| K981229 | MANAN MANTA CATHETER FIXATION DISK | Medical Device Technologies, Inc. | 1998-04-22 |
| K972977 | INSULATOR WIRE GUIDE | Cook Urological, Inc. | 1997-10-10 |
| K960866 | LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. | Lake Region Mfg., Inc. | 1996-04-05 |
| K954132 | MANAN MANTA CATHETER FIXATION DISK | Manan Medical Products, Inc. | 1996-03-26 |
| K952414 | PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER | Acacia Laboratories, Inc. | 1995-06-23 |
| K951995 | KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR | Karl Storz Endoskop GmbH | 1995-05-24 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 50192253027646 | Dover | Cardinal Health 200, LLC | 2024-07-10 |
| 10192253032338 | Dover | Cardinal Health 200, LLC | 2024-07-10 |
| 03700512986225 | Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cm | Promepla | 2017-11-09 |
| 03700512986218 | Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cm | Promepla | 2017-11-09 |
| 03700512986201 | Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm | Promepla | 2017-11-09 |
| 03700512986195 | Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cm | Promepla | 2017-11-09 |
| 10680651445787 | Halyard | Avanos Medical, Inc. | 2017-05-10 |
| 00821925035171 | UroPass Ureteral Access Sheath | Gyrus Acmi, Inc. | 2016-10-03 |
| 00821925035164 | UroPass Ureteral Access Sheath | Gyrus Acmi, Inc. | 2016-10-03 |
| 00821925035157 | UroPass Ureteral Access Sheath | Gyrus Acmi, Inc. | 2016-10-03 |
| 03700512983613 | BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cm | Promepla | 2016-10-03 |
| 03700512983606 | BI-FLEX ACCESS SHEATH - 10 inner / 12 outer - Length 45cm | Promepla | 2016-10-03 |
| 03700512983590 | BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cm | Promepla | 2016-10-03 |
| 20884521007816 | Dover | Cardinal Health, Inc. | 2016-09-24 |
| 04048551086025 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 03700512985594 | RocaFlex Access Sheath & Dilation Catheter 12/14x35cm | Promepla | 2016-09-14 |
| 03700512985617 | RocaFlex Access Sheath & Dilation Catheter 12/14x45cm | Promepla | 2016-09-14 |
| 03700512985600 | RocaFlex Access Sheath & Dilation Catheter 10/12x45cm | Promepla | 2016-09-14 |
| 03700512985587 | RocaFlex Access Sheath & Dilation Catheter 10/12x35cm | Promepla | 2016-09-14 |
| 10801741052504 | Bard® "C" Clamp | C. R. Bard, Inc. | 2016-08-25 |
| 10801741046244 | Bard® Large Nylon Catheter Plug | C. R. Bard, Inc. | 2016-08-22 |
| 10801741046251 | Bard® Small Nylon Catheter Plug | C. R. Bard, Inc. | 2016-08-22 |
| 03700512963585 | Bi-Flex | Promepla | 2016-07-19 |
| 30607915123056 | ACUCISE® CUSTOM KIT | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-16 |
| 30607915123759 | STONE CENTER SILHOUETTE | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-16 |
| 20607915125947 | ACUCISE® PROCEDURAL PACK STARTER PACK | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128122 | ACUCISE® PROCEDURAL PACK UNIVERSAL PACK A | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128139 | ACUCISE® PROCEDURAL PACK UNIVERSAL PACK B | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128146 | ACUCISE® PROCEDURAL PACK UNIVERSAL PACK C | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128191 | ACUCISE® PROCEDURAL PACK FEMALE PACK B | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |