Product code HIB
- 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
- Source
- FDA openFDA device classification dataset
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 |
|---|---|---|---|
| M648C0206000 | HER-SPEC | OBP CORPORATION | 2019-10-23 |
| M648C0205200 | HER-SPEC | OBP CORPORATION | 2019-10-23 |
| M648C0205100 | HER-SPEC | OBP CORPORATION | 2019-10-23 |
| M648C0205000 | HER-SPEC | OBP CORPORATION | 2019-10-23 |
| 10352410462433 | MedPride | SHIELD-LINE, LLC | 2019-08-12 |
| 10352410462440 | MedPride | SHIELD-LINE, LLC | 2019-08-12 |
| 10352410462457 | MedPride | SHIELD-LINE, LLC | 2019-08-12 |
| M648C02014010 | ER-SPEC | OBP CORPORATION | 2018-09-28 |
| 10653160307556 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2017-03-03 |
| M648C02013010 | ER-SPEC/OFFICE-SPEC | OBP CORPORATION | 2017-02-28 |
| M220P2501002 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2017-02-13 |
| M220P2503002 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2017-02-13 |
| M220P5202002 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2017-02-13 |
| 10080196806485 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196807116 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196806478 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10704411002253 | AMSure® Disposable Vaginal Speculum | AMSINO INTERNATIONAL, INC. | 2016-09-23 |
| 10704411002260 | AMSure® Disposable Vaginal Speculum | AMSINO INTERNATIONAL, INC. | 2016-09-23 |
| 10704411002277 | AMSure® Disposable Vaginal Speculum | AMSINO INTERNATIONAL, INC. | 2016-09-23 |
| M20890027843 | CUSTOMED | CUSTOMED INC | 2016-09-23 |
| M20890027833 | CUSTOMED | CUSTOMED INC | 2016-09-23 |
| M20890027823 | CUSTOMED | CUSTOMED INC | 2016-09-23 |
| M648C0200010 | OFFICESPEC | OBP CORPORATION | 2016-09-22 |
| M648C02010010 | ER-SPEC/OFFICE-SPEC | OBP CORPORATION | 2016-09-22 |
| M648C02011010 | ER-SPEC/OFFICE-SPEC | OBP CORPORATION | 2016-09-22 |
| M648C02012010 | ER-SPEC/OFFICESPEC | OBP CORPORATION | 2016-09-22 |
| M648C0203000 | ER-SPEC/OFFICE-SPEC | OBP CORPORATION | 2016-09-22 |
| M648C0203100 | ER-SPEC/OFFICE-SPEC | OBP CORPORATION | 2016-09-22 |
| M648C0203200 | ER-SPEC/OFFICE-SPEC | OBP CORPORATION | 2016-09-22 |
| 10653160268994 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2016-09-14 |