Product code HIB
- 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
- Speculum, Vaginal, Nonmetal
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4530
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
Related Records
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252208 | JFord Speculum Sleeve | Ford Medtech, LLC | 2026-03-06 |
| K133857 | BRELLA-SPEC(TM) VAGINAL SPECULUM | Proa Medical, Inc. | 2014-04-28 |
| K132668 | IOB DISPOSABLE SPECULUM | Iob Medical, Inc. | 2014-01-17 |
| K130046 | CLEARSPEC SINGLE USE VAGINAL SPECULUM | Clearspec, LLC | 2013-08-06 |
| K120743 | SPECULUM, VAGINAL, NONMETAL | Welch Allyn, Inc. | 2012-03-23 |
| K110766 | KOLPLUX SYSTEM | Kolplast CI Ltda | 2011-09-15 |
| K092870 | NON-STERILE DISPOSABLE VAGINAL SPECULUM | Kunshan Deyi Plastic Co., Ltd. | 2010-02-16 |
| K091937 | OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM | Obp Corporation | 2009-09-09 |
| K072942 | MEDLINE DISPOSABLE VAGINAL SPECULUM | Medline Industries, Inc. | 2008-02-08 |
| K072762 | DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM | Depalt, Inc. | 2008-01-22 |
| K070964 | KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM | Welch Allyn, Inc. | 2007-05-18 |
| K061339 | HIERSPEC SPECULUM | Medical Products Div. | 2006-09-19 |
| K060129 | IGS VAGINAL SPECULUM | Innovative Gynecological Solutions, LLC | 2006-05-04 |
| K052420 | G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM | Gynova, LLC | 2006-04-06 |
| K052192 | FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I | Femspec LLC | 2006-02-02 |
| K052912 | YUSHENG DISPOSABLE VAGINAL SPECULUM | Zhejiang Yusheng Medical Instrument Co. , Ltd. | 2005-12-15 |
| K052314 | DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE | Dynarex Corp. | 2005-11-09 |
| K050887 | GONGDONG DISPOSABLE VAGINAL SPECULUM | Zhejiang Gongdong Medical Plastic Factory | 2005-07-11 |
| K041757 | FEMSPEC DISPOSABLE VAGINAL SPECULUM | Femspec LLC | 2004-12-23 |
| K042950 | VAG O SPECULUM, MODELS VS1, VM1, VL1 | Panatrex, Inc. | 2004-11-30 |
| K040817 | POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM | Advanced Urological Developments | 2004-06-22 |
| K030693 | KENTEX DISPOSABLE VAGINAL SPECULUM | Kentron Health Care, Inc. | 2003-08-27 |
| K030761 | KAISHOU VAGINAL SPECULUM | Jiangsu Kaishou Medical Apparatus Co., Ltd. | 2003-06-09 |
| K022948 | VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L | Medical Action Industries, Inc. | 2002-11-04 |
| K021849 | TAGG DISPOSABLE VAGINAL SPECULUM | Tagg Industries | 2002-07-16 |
| K021676 | CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL | Cypress Medical Products, Ltd. | 2002-07-12 |
| K021017 | LEESPEC DISPOSABLE VAGINAL SPECULUM | Itl Corporation Pty, Ltd. | 2002-06-19 |
| K020959 | GLO-SPEC I, II AND III | Sol Weiss MD, Inc. | 2002-06-19 |
| K020726 | DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE | Dukal Corp. | 2002-05-15 |
| K012535 | DRG DISPOSABLE VAGINAL SPECULUM | Doctor'S Research Group, Inc. | 2002-03-01 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 40199536930016 | Blueline | Transparent Supply Solutions Ltd. | 2025-09-22 |
| 40199536930023 | Blueline | Transparent Supply Solutions Ltd. | 2025-09-22 |
| 40199536930030 | Blueline | Transparent Supply Solutions Ltd. | 2025-09-22 |
| 40199536930047 | Blueline | Transparent Supply Solutions Ltd. | 2025-09-22 |
| 40199536930054 | Blueline | Transparent Supply Solutions Ltd. | 2025-09-22 |
| 40199536930009 | Blueline | Transparent Supply Solutions Ltd. | 2025-09-22 |
| 05010058191570 | Ultraspec | ROBINSON HEALTHCARE LIMITED | 2025-06-18 |
| 05010058191532 | Ultraspec | ROBINSON HEALTHCARE LIMITED | 2025-06-18 |
| 05010058191495 | Ultraspec | ROBINSON HEALTHCARE LIMITED | 2025-06-18 |
| 05010058191471 | Ultraspec | ROBINSON HEALTHCARE LIMITED | 2025-06-18 |
| 05010058191457 | Ultraspec | ROBINSON HEALTHCARE LIMITED | 2025-06-18 |
| 05010058191426 | Ultraspec | ROBINSON HEALTHCARE LIMITED | 2025-05-21 |
| 16972903333237 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903333220 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903333213 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903333138 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903333121 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903333114 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903332230 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903332223 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903332216 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903331233 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903331226 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903331219 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903331134 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903331127 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903331110 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903330038 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 16972903330021 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |
| 06972903330017 | SHENGBO | YUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD. | 2025-05-11 |