FDA Product Code
FDA Product Code HIB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4530
510(k) Clearances — 72 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252208 | JFord Speculum Sleeve | Ford Medtech, LLC | 2026-03-06 | Traditional | PDF ↗ |
| K133857 | BRELLA-SPEC(TM) VAGINAL SPECULUM | Proa Medical, Inc. | 2014-04-28 | Traditional | PDF ↗ |
| K132668 | IOB DISPOSABLE SPECULUM | Iob Medical, Inc. | 2014-01-17 | Traditional | PDF ↗ |
| K130046 | CLEARSPEC SINGLE USE VAGINAL SPECULUM | Clearspec, LLC | 2013-08-06 | Traditional | PDF ↗ |
| K120743 | SPECULUM, VAGINAL, NONMETAL | Welch Allyn, Inc. | 2012-03-23 | Special | PDF ↗ |
| K110766 | KOLPLUX SYSTEM | Kolplast CI Ltda | 2011-09-15 | Traditional | PDF ↗ |
| K092870 | NON-STERILE DISPOSABLE VAGINAL SPECULUM | Kunshan Deyi Plastic Co., Ltd. | 2010-02-16 | Traditional | PDF ↗ |
| K091937 | OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM | Obp Corporation | 2009-09-09 | Traditional | PDF ↗ |
| K072942 | MEDLINE DISPOSABLE VAGINAL SPECULUM | Medline Industries, Inc. | 2008-02-08 | Traditional | PDF ↗ |
| K072762 | DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM | Depalt, Inc. | 2008-01-22 | Traditional | PDF ↗ |
| K070964 | KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM | Welch Allyn, Inc. | 2007-05-18 | Special | PDF ↗ |
| K061339 | HIERSPEC SPECULUM | Medical Products Div. | 2006-09-19 | Traditional | PDF ↗ |
| K060129 | IGS VAGINAL SPECULUM | Innovative Gynecological Solutions, LLC | 2006-05-04 | Traditional | PDF ↗ |
| K052420 | G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM | Gynova, LLC | 2006-04-06 | Traditional | PDF ↗ |
| K052192 | FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I | Femspec LLC | 2006-02-02 | Traditional | PDF ↗ |
| K052912 | YUSHENG DISPOSABLE VAGINAL SPECULUM | Zhejiang Yusheng Medical Instrument Co. , Ltd. | 2005-12-15 | Traditional | PDF ↗ |
| K052314 | DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE | Dynarex Corp. | 2005-11-09 | Traditional | PDF ↗ |
| K050887 | GONGDONG DISPOSABLE VAGINAL SPECULUM | Zhejiang Gongdong Medical Plastic Factory | 2005-07-11 | Abbreviated | PDF ↗ |
| K041757 | FEMSPEC DISPOSABLE VAGINAL SPECULUM | Femspec LLC | 2004-12-23 | Traditional | PDF ↗ |
| K042950 | VAG O SPECULUM, MODELS VS1, VM1, VL1 | Panatrex, Inc. | 2004-11-30 | Traditional | PDF ↗ |
| K040817 | POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM | Advanced Urological Developments | 2004-06-22 | Traditional | PDF ↗ |
| K030693 | KENTEX DISPOSABLE VAGINAL SPECULUM | Kentron Health Care, Inc. | 2003-08-27 | Traditional | PDF ↗ |
| K030761 | KAISHOU VAGINAL SPECULUM | Jiangsu Kaishou Medical Apparatus Co., Ltd. | 2003-06-09 | Traditional | PDF ↗ |
| K022948 | VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L | Medical Action Industries, Inc. | 2002-11-04 | Traditional | PDF ↗ |
| K021849 | TAGG DISPOSABLE VAGINAL SPECULUM | Tagg Industries | 2002-07-16 | Traditional | PDF ↗ |
| K021676 | CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL | Cypress Medical Products, Ltd. | 2002-07-12 | Traditional | PDF ↗ |
| K021017 | LEESPEC DISPOSABLE VAGINAL SPECULUM | Itl Corporation Pty, Ltd. | 2002-06-19 | Traditional | PDF ↗ |
| K020959 | GLO-SPEC I, II AND III | Sol Weiss MD, Inc. | 2002-06-19 | Traditional | PDF ↗ |
| K020726 | DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE | Dukal Corp. | 2002-05-15 | Traditional | PDF ↗ |
| K012535 | DRG DISPOSABLE VAGINAL SPECULUM | Doctor'S Research Group, Inc. | 2002-03-01 | Traditional | PDF ↗ |
| K013835 | GLOBAL HEALTHCARE VAGINAL SPECULUM | Dynascend Consulting Int'L, LLC | 2002-01-17 | Traditional | PDF ↗ |
| K013817 | GLO-SPEC | Sol Weiss MD, Inc. | 2001-12-21 | Traditional | PDF ↗ |
| K012859 | NU-SPEC D | Sol Weiss MD, Inc. | 2001-10-26 | Traditional | PDF ↗ |
| K002912 | VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 | Sterinc | 2001-02-21 | Traditional | PDF ↗ |
| K003540 | (DISPOSABLE) VAGINAL SPECULUM | Feminica, Inc. | 2001-02-09 | Traditional | PDF ↗ |
| K000444 | MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM | Prism Enterprises, Inc. | 2000-04-21 | Traditional | PDF ↗ |
| K000414 | MEDISUL DISPOSABLE VAGINAL SPECULUM | Marketing Perspectives | 2000-04-04 | Abbreviated | PDF ↗ |
| K992736 | WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM | Wallach Surgical Devices, Inc. | 1999-09-29 | Traditional | PDF ↗ |
| K991963 | PATTON SPECULUM | Patton Medical Corp. | 1999-09-01 | Traditional | PDF ↗ |
| K991827 | GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 | Ri Mos. S.R.L. | 1999-07-19 | Traditional | PDF ↗ |
| K984211 | MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 | Medscand AB | 1998-12-23 | Traditional | PDF ↗ |
| K983716 | VITALCARE DISPOSABLE VAGINAL SPECULUM | Vitalcare Group, Inc. | 1998-12-23 | Traditional | PDF ↗ |
| K973853 | KOLPLAST VAGINAL SPECULUM | Kolplast Comercial E Industrial Ltda | 1997-12-19 | Traditional | PDF ↗ |
| K974228 | HOSPITAL'S SPEC | Gps | 1997-12-12 | Traditional | PDF ↗ |
| K971979 | PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS | Playtex Products, Inc. | 1997-09-26 | Traditional | PDF ↗ |
| K925501 | NYLON COATED SPECULA | Zinnanti Surgical Instruments, Inc. | 1997-06-13 | Traditional | PDF ↗ |
| K963377 | EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC | North Eos Industries, Inc. | 1996-10-04 | Traditional | PDF ↗ |
| K951898 | VERSA-VU | CooperSurgical, Inc. | 1995-12-11 | Traditional | PDF ↗ |
| K951528 | AMSINO DISPOSABLE VIGINAL SPECULUM | Amsino Intl., Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K941272 | KLEENSPEC | Welch Allyn, Inc. | 1994-08-02 | Traditional | PDF ↗ |
| K930954 | THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV | Cabot Medical Corp. | 1994-06-30 | Traditional | PDF ↗ |
| K922154 | INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION | Olsen Electrosurgical, Inc. | 1994-04-21 | Traditional | PDF ↗ |
| K935636 | GRAVESPEC | Adept-Med Intl., Inc. | 1994-03-25 | Traditional | PDF ↗ |
| K933521 | SPECULUM | Bioteque America, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K926536 | DISPOSABLE PLASTIC VAGINAL SPECULA | Thomasville Medical Assoc. | 1994-02-25 | Traditional | PDF ↗ |
| K920803 | HSG TRAY | Unimar, Inc. | 1992-10-19 | Traditional | PDF ↗ |
| K903080 | DISPOSABLE PLASTIC VAGINAL SPECULUM | Dawnex Industries, Inc. | 1990-09-19 | Traditional | PDF ↗ |
| K903744 | PHYSICIAN'S CHOICE | Advance Medical Device, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K894957 | DISPOSABLE PLASTIC VAGINAL SPECULA | Zinnanti Surgical Instruments, Inc. | 1989-10-12 | Traditional | PDF ↗ |
| K894489 | GYNECOLOGIC EXAMINATION KIT | A & A Medical, Inc. | 1989-10-05 | Traditional | PDF ↗ |
| K880588 | AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4 | C.I.S.A. Import Export C/O Larson and Taylor | 1988-12-20 | Traditional | PDF ↗ |
| K880587 | AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3 | C.I.S.A. Import Export C/O Larson and Taylor | 1988-12-20 | Traditional | PDF ↗ |
| K880586 | AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2 | C.I.S.A. Import Export C/O Larson and Taylor | 1988-12-20 | Traditional | PDF ↗ |
| K882605 | EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM | Buckman Co., Inc. | 1988-09-15 | Traditional | PDF ↗ |
| K863275 | MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM | Martin Medical | 1986-09-02 | Traditional | PDF ↗ |
| K863274 | MARTIN MEDICAL PRO-SPEC MEDIUM VAGINAL SPECULUM | Martin Medical | 1986-09-02 | Traditional | PDF ↗ |
| K842014 | HOSPITAL'S-SPEC | Merex Co. | 1984-08-17 | Traditional | PDF ↗ |
| K841909 | VAGINAL SPECULUM - DISPOSABLE | Galenica Enterprises, Inc. | 1984-07-31 | Traditional | PDF ↗ |
| K841867 | KIDD VAGINAL SPECULUM | Paul H. Schneider Ent. | 1984-07-13 | Traditional | PDF ↗ |
| K830725 | GENT-L-SPEC DISPOS. VAGINAL SPECULUM | Geneva Laboratories, Inc. | 1983-04-27 | Traditional | PDF ↗ |
| K822086 | DIA-SPEC | Exitec, Inc. | 1982-11-08 | Traditional | PDF ↗ |
| K822084 | PRO-SPEC | Exitec, Inc. | 1982-08-19 | Traditional | PDF ↗ |
Product code HIB · Class II · Obstetrics/Gynecology. Data: openFDA.