Product code MQE
- 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
- Needle, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.6100
- Review panel
- OB
- 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 |
|---|---|---|---|
| K240523 | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) | Shenzhen Vitavitro Biotech Co., Ltd. | 2024-11-15 |
| K232163 | Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle | Zhejiang Horizon Medical Technology Co., Ltd. | 2024-02-22 |
| K190590 | Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) | Allwin Medical Devices, Inc. | 2019-11-25 |
| K191291 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | 2019-06-12 |
| K182959 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | 2019-05-10 |
| K171625 | Single Lumen Ovum Aspiration Needles | Willian A. Cook Australia Pty, Ltd. | 2018-01-12 |
| K171611 | Double Lumen Ovum Aspiration Needles | William A. Cook Australia Pty. , Ltd. | 2017-12-15 |
| K172050 | Follicle Aspiration Set, Reduced Single Lumen | Vitrolife Sweden AB | 2017-11-21 |
| K162881 | Kitazato OPU Needles | Kitazato Corporation | 2017-07-11 |
| K161970 | Follicle Aspiration Set | Vitrolife Sweden AB | 2017-06-14 |
| K141365 | OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN | William A. Cook Australia Pty. , Ltd. | 2014-08-07 |
| K112462 | KITAZATO OPU NEEDLE | Kitazato Medical Co., Ltd. | 2012-11-26 |
| K082727 | FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN | Vitrolife Sweden AB | 2009-02-06 |
| K051742 | OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH | Inntec, Inc. | 2005-10-07 |
| K032208 | MONA LISA ASPIRATION NEEDLE | Fertility Technology Resources, Inc. | 2003-12-09 |
| K032015 | EMBRYON ULTRASOUND NEEDLE GUIDE | Rocket Medical Plc | 2003-08-08 |
| K031622 | WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS | Portex , Ltd. | 2003-06-26 |
| K023930 | COOPERSURGICAL OOCYTE RECOVERY NEEDLES | CooperSurgical, Inc. | 2003-01-22 |
| K013497 | FAS SET #4551 | Gynetics Medical Products NV | 2001-11-09 |
| K012068 | WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S | Sims Portex , Ltd. | 2001-08-03 |
| K003056 | OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218 | Labotect Labor-Technik Gottingen | 2000-12-13 |
| K000205 | EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES | Rocket Medical Plc | 2000-04-19 |
| K000628 | WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 | Sims Portex , Ltd. | 2000-03-13 |
| K991271 | OOCYTE ASPIRATION NEEDLE | Casmed UK | 2000-03-08 |
| K994417 | OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING | Cook Urological, Inc. | 2000-03-01 |
| K992308 | OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138 | Lifetek Medical, Inc. | 1999-09-13 |
| K991020 | <GENX> DOUBLE LUMEN NEEDLE | <Genx> Intl., Inc. | 1999-09-09 |
| K991262 | <GEN>SINGLE LUMEN NEEDLE | <Genx> Intl., Inc. | 1999-09-09 |
| K991264 | <GENX> SINGLE LUMEN SIDEPORT NEEDLE | <Genx> Intl., Inc. | 1999-09-09 |
| K991273 | SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE | Swemed Lab International AB | 1999-08-18 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06971982050304 | VitaVitro | Shenzhen Vitavitro Bio-Tech Co.,Ltd | 2024-12-06 |
| 06971982050311 | VitaVitro | Shenzhen Vitavitro Bio-Tech Co.,Ltd | 2024-12-06 |
| 06971982050298 | VitaVitro | Shenzhen Vitavitro Bio-Tech Co.,Ltd | 2024-12-06 |
| 17350025915477 | Follicle Aspiration Set Reduced Single Lumen, Luer | Vitrolife Sweden AB | 2024-11-26 |
| 17350025915484 | Follicle Aspiration Set Reduced Single Lumen, Luer | Vitrolife Sweden AB | 2024-11-26 |
| 17350025915682 | Follicle Aspiration Set Reduced Single Lumen | Vitrolife Sweden AB | 2024-07-02 |
| 17350025915699 | Follicle Aspiration Set Single Lumen | Vitrolife Sweden AB | 2024-07-02 |
| 00841436123051 | Needle Guide | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2024-06-20 |
| 00841436123228 | Needle Guide | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2024-06-20 |
| 00841436122351 | Needle Guide | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2024-06-20 |
| 00841436123099 | Needle Guide | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2024-06-20 |
| 00841436122290 | Needle Guide | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2024-06-20 |
| 00841436122269 | Needle Guide | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2024-06-20 |
| 00841436123068 | Needle Guide | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2024-06-20 |
| 00841436122214 | Needle Guide | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2024-06-20 |
| 14580745043706 | OPU Needle | KITAZATO CORPORATION | 2024-05-16 |
| 14580745043737 | OPU Needle | KITAZATO CORPORATION | 2024-05-16 |
| 14580745043720 | OPU Needle | KITAZATO CORPORATION | 2024-05-16 |
| 00812261016597 | ASPI | ALLWIN MEDICAL DEVICES, INC. | 2024-01-09 |
| 03700111425804 | HOC CLASSIC WITH VALVE Aspiration tube 2 x 33 cm | LABORATOIRE CCD | 2023-12-05 |
| 03700111425811 | HOC CLASSIC WITHOUT VALVE Aspiration tube 67 cm | LABORATOIRE CCD | 2023-12-05 |
| 03700111425828 | HOC2 CLASSIC WITHOUT VALVE SOFT PLUG | LABORATOIRE CCD | 2023-12-05 |
| 03700111425835 | OPS CLASSIC WITHOUT VALVE | LABORATOIRE CCD | 2023-12-05 |
| 03700111425842 | OPS CLASSIC WITH VALVE | LABORATOIRE CCD | 2023-12-05 |
| 03700111425866 | HOC COLLECTION VIAL 30ML | LABORATOIRE CCD | 2023-12-05 |
| 03700111425910 | OPS A.R.T. OF C.C.D. ® WITHOUT VALVE | LABORATOIRE CCD | 2023-12-05 |
| 03700111425927 | OPS A.R.T. OF C.C.D. ®WITH VALVE | LABORATOIRE CCD | 2023-12-05 |
| 03700111425934 | HOC A.R.T. OF C.C.D.® WITHOUT VALVE | LABORATOIRE CCD | 2023-12-05 |
| 03700111425941 | HOC A.R.T. OF C.C.D.® WITH VALVE | LABORATOIRE CCD | 2023-12-05 |
| 03700111425958 | HOC2 A.R.T. OF C.C.D.® WITHOUT VALVE SOFT PLUG | LABORATOIRE CCD | 2023-12-05 |