Product Code: HIB
FDA class 2
21 CFR 884.4530
Speculum, Vaginal, Nonmetal
Obstetrics/Gynecology
The Nonmetal Vaginal Speculum is a gynecological instrument made of plastic or other non-metallic material used to dilate the vaginal canal and expose the cervix for visual examination, specimen collection, or minor procedures during pelvic examinations. It is classified as FDA Class 2 (moderate risk) within the Obstetrics/Gynecology specialty, subject to premarket controls. The product code is HIB, regulated under 21 CFR 884.4530. No special risk flags apply.
510(k)s
71
FEI Numbers
122
Registration Numbers
122
Unique Applicants
61
Years Active
32
Basic Information
- Product Code
- HIB
- Device Class
- FDA class 2
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 71 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K133857 | BRELLA-SPEC(TM) VAGINAL SPECULUM | Apr 28, 2014 | Substantially Equivalent | PROA MEDICAL, INC. |
| K132668 | IOB DISPOSABLE SPECULUM | Jan 17, 2014 | Substantially Equivalent | IOB MEDICAL INC |
| K130046 | CLEARSPEC SINGLE USE VAGINAL SPECULUM | Aug 06, 2013 | Substantially Equivalent | CLEARSPEC LLC |
| K120743 | SPECULUM, VAGINAL, NONMETAL | Mar 23, 2012 | Substantially Equivalent | WELCH ALLYN, INC. |
| K110766 | KOLPLUX SYSTEM | Sep 15, 2011 | Substantially Equivalent | KOLPLAST CI LTDA |
| K092870 | NON-STERILE DISPOSABLE VAGINAL SPECULUM | Feb 16, 2010 | Substantially Equivalent | KUNSHAN DEYI PLASTIC CO., LTD. |
| K091937 | OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM | Sep 09, 2009 | Substantially Equivalent | OBP CORPORATION |
| K072942 | MEDLINE DISPOSABLE VAGINAL SPECULUM | Feb 08, 2008 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K072762 | DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM | Jan 22, 2008 | Substantially Equivalent | DEPALT INC. |
| K070964 | KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM | May 18, 2007 | Substantially Equivalent | WELCH ALLYN, INC. |
| K061339 | HIERSPEC SPECULUM | Sep 19, 2006 | Substantially Equivalent | MEDICAL PRODUCTS DIV. |
| K060129 | IGS VAGINAL SPECULUM | May 04, 2006 | Substantially Equivalent | INNOVATIVE GYNECOLOGICAL SOLUTIONS LLC |
| K052420 | G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM | Apr 06, 2006 | Substantially Equivalent | GYNOVA, LLC |
| K052192 | FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I | Feb 02, 2006 | Substantially Equivalent | FEMSPEC L.L.C. |
| K052912 | YUSHENG DISPOSABLE VAGINAL SPECULUM | Dec 15, 2005 | Substantially Equivalent | ZHEJIANG YUSHENG MEDICAL INSTRUMENT CO. LTD. |
| K052314 | DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE | Nov 09, 2005 | Substantially Equivalent | DYNAREX CORP. |
| K050887 | GONGDONG DISPOSABLE VAGINAL SPECULUM | Jul 11, 2005 | Substantially Equivalent | ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY |
| K041757 | FEMSPEC DISPOSABLE VAGINAL SPECULUM | Dec 23, 2004 | Substantially Equivalent | FEMSPEC L.L.C. |
| K042950 | VAG O SPECULUM, MODELS VS1, VM1, VL1 | Nov 30, 2004 | Substantially Equivalent | PANATREX, INC. |
| K040817 | POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM | Jun 22, 2004 | Substantially Equivalent | ADVANCED UROLOGICAL DEVELOPMENTS |
| K030693 | KENTEX DISPOSABLE VAGINAL SPECULUM | Aug 27, 2003 | Substantially Equivalent | KENTRON HEALTH CARE, INC. |
| K030761 | KAISHOU VAGINAL SPECULUM | Jun 09, 2003 | Substantially Equivalent | JIANGSU KAISHOU MEDICAL APPARATUS CO., LTD |
| K022948 | VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L | Nov 04, 2002 | Substantially Equivalent | MEDICAL ACTION INDUSTRIES, INC. |
| K021849 | TAGG DISPOSABLE VAGINAL SPECULUM | Jul 16, 2002 | Substantially Equivalent | TAGG INDUSTRIES |
| K021676 | CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL | Jul 12, 2002 | Substantially Equivalent | CYPRESS MEDICAL PRODUCTS, LTD. |
| K021017 | LEESPEC DISPOSABLE VAGINAL SPECULUM | Jun 19, 2002 | Substantially Equivalent | ITL CORPORATION, PTY LTD. |
| K020959 | GLO-SPEC I, II AND III | Jun 19, 2002 | Substantially Equivalent | SOL WEISS MD INC |
| K020726 | DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE | May 15, 2002 | Substantially Equivalent | DUKAL CORP. |
| K012535 | DRG DISPOSABLE VAGINAL SPECULUM | Mar 01, 2002 | Substantially Equivalent | DOCTOR'S RESEARCH GROUP, INC. |
| K013835 | GLOBAL HEALTHCARE VAGINAL SPECULUM | Jan 17, 2002 | Substantially Equivalent | DYNASCEND CONSULTING INT'L LLC. |
| K013817 | GLO-SPEC | Dec 21, 2001 | Substantially Equivalent | SOL WEISS MD INC |
| K012859 | NU-SPEC D | Oct 26, 2001 | Substantially Equivalent | SOL WEISS MD INC |
| K002912 | VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 | Feb 21, 2001 | Substantially Equivalent | STERINC |
| K003540 | (DISPOSABLE) VAGINAL SPECULUM | Feb 09, 2001 | Substantially Equivalent | FEMINICA, INC. |
| K000444 | MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM | Apr 21, 2000 | Substantially Equivalent | PRISM ENTERPRISES, INC. |
| K000414 | MEDISUL DISPOSABLE VAGINAL SPECULUM | Apr 04, 2000 | Substantially Equivalent | MARKETING PERSPECTIVES |
| K992736 | WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM | Sep 29, 1999 | Substantially Equivalent | WALLACH SURGICAL DEVICES, INC. |
| K991963 | PATTON SPECULUM | Sep 01, 1999 | Substantially Equivalent | PATTON MEDICAL CORP. |
| K991827 | GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 | Jul 19, 1999 | Substantially Equivalent | RI MOS. S.R.L. |
| K984211 | MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 | Dec 23, 1998 | Substantially Equivalent | MEDSCAND AB |
| K983716 | VITALCARE DISPOSABLE VAGINAL SPECULUM | Dec 23, 1998 | Substantially Equivalent | VITALCARE GROUP, INC. |
| K973853 | KOLPLAST VAGINAL SPECULUM | Dec 19, 1997 | Substantially Equivalent | KOLPLAST COMERCIAL E INDUSTRIAL LTDA |
| K974228 | HOSPITAL'S SPEC | Dec 12, 1997 | Substantially Equivalent | GPS |
| K971979 | PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS | Sep 26, 1997 | Substantially Equivalent | PLAYTEX PRODUCTS, INC. |
| K925501 | NYLON COATED SPECULA | Jun 13, 1997 | Substantially Equivalent | ZINNANTI SURGICAL INSTRUMENTS, INC. |
| K963377 | EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC | Oct 04, 1996 | Substantially Equivalent | NORTH EOS INDUSTRIES, INC. |
| K951898 | VERSA-VU | Dec 11, 1995 | Substantially Equivalent | COOPERSURGICAL, INC. |
| K951528 | AMSINO DISPOSABLE VIGINAL SPECULUM | May 11, 1995 | Substantially Equivalent | AMSINO INTL., INC. |
| K941272 | KLEENSPEC | Aug 02, 1994 | Substantially Equivalent | WELCH ALLYN, INC. |
| K930954 | THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV | Jun 30, 1994 | Substantially Equivalent | CABOT MEDICAL CORP. |
| K922154 | INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION | Apr 21, 1994 | Substantially Equivalent | OLSEN ELECTROSURGICAL, INC. |
| K935636 | GRAVESPEC | Mar 25, 1994 | Substantially Equivalent | ADEPT-MED INTL., INC. |
| K933521 | SPECULUM | Mar 07, 1994 | Substantially Equivalent | BIOTEQUE AMERICA, INC. |
| K926536 | DISPOSABLE PLASTIC VAGINAL SPECULA | Feb 25, 1994 | Substantially Equivalent | THOMASVILLE MEDICAL ASSOC. |
| K920803 | HSG TRAY | Oct 19, 1992 | Unknown | UNIMAR, INC. |
| K903080 | DISPOSABLE PLASTIC VAGINAL SPECULUM | Sep 19, 1990 | Substantially Equivalent | DAWNEX INDUSTRIES, INC. |
| K903744 | PHYSICIAN'S CHOICE | Sep 12, 1990 | Substantially Equivalent | ADVANCE MEDICAL DEVICE, INC. |
| K894957 | DISPOSABLE PLASTIC VAGINAL SPECULA | Oct 12, 1989 | Substantially Equivalent | ZINNANTI SURGICAL INSTRUMENTS, INC. |
| K894489 | GYNECOLOGIC EXAMINATION KIT | Oct 05, 1989 | Substantially Equivalent | A & A MEDICAL, INC. |
| K880588 | AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4 | Dec 20, 1988 | Substantially Equivalent | C.I.S.A. IMPORT EXPORT C/O LARSON AND TAYLOR |
| K880587 | AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3 | Dec 20, 1988 | Substantially Equivalent | C.I.S.A. IMPORT EXPORT C/O LARSON AND TAYLOR |
| K880586 | AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2 | Dec 20, 1988 | Substantially Equivalent | C.I.S.A. IMPORT EXPORT C/O LARSON AND TAYLOR |
| K882605 | EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM | Sep 15, 1988 | Substantially Equivalent | BUCKMAN CO., INC. |
| K863275 | MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM | Sep 02, 1986 | Substantially Equivalent | MARTIN MEDICAL |
| K863274 | MARTIN MEDICAL PRO-SPEC MEDIUM VAGINAL SPECULUM | Sep 02, 1986 | Substantially Equivalent | MARTIN MEDICAL |
| K842014 | HOSPITAL'S-SPEC | Aug 17, 1984 | Substantially Equivalent | MEREX CO. |
| K841909 | VAGINAL SPECULUM - DISPOSABLE | Jul 31, 1984 | Substantially Equivalent | GALENICA ENTERPRISES, INC. |
| K841867 | KIDD VAGINAL SPECULUM | Jul 13, 1984 | Substantially Equivalent | PAUL H. SCHNEIDER ENT. |
| K830725 | GENT-L-SPEC DISPOS. VAGINAL SPECULUM | Apr 27, 1983 | Substantially Equivalent | GENEVA LABORATORIES, INC. |
| K822086 | DIA-SPEC | Nov 08, 1982 | Substantially Equivalent | EXITEC, INC. |
| K822084 | PRO-SPEC | Aug 19, 1982 | Substantially Equivalent | EXITEC, INC. |
FEI Numbers
This FDA classification entry is associated with 122 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 122 registration numbers. Click on an entry to view related FDA registrations.