FDA 510(k) Applications for Medical Device Product Code "HIB"
(Speculum, Vaginal, Nonmetal)

FDA 510(k) Number Applicant Device Name Decision Date
K040817 ADVANCED UROLOGICAL DEVELOPMENTS POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM 06/22/2004
K130046 CLEARSPEC LLC CLEARSPEC SINGLE USE VAGINAL SPECULUM 08/06/2013
K021676 CYPRESS MEDICAL PRODUCTS, LTD. CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL 07/12/2002
K072762 DEPALT INC. DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM 01/22/2008
K012535 DOCTOR'S RESEARCH GROUP, INC. DRG DISPOSABLE VAGINAL SPECULUM 03/01/2002
K020726 DUKAL CORP. DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE 05/15/2002
K052314 DYNAREX CORP. DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE 11/09/2005
K013835 DYNASCEND CONSULTING INT'L LLC. GLOBAL HEALTHCARE VAGINAL SPECULUM 01/17/2002
K003540 FEMINICA, INC. (DISPOSABLE) VAGINAL SPECULUM 02/09/2001
K052192 FEMSPEC L.L.C. FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I 02/02/2006
K041757 FEMSPEC L.L.C. FEMSPEC DISPOSABLE VAGINAL SPECULUM 12/23/2004
K974228 GPS HOSPITAL'S SPEC 12/12/1997
K052420 GYNOVA, LLC G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM 04/06/2006
K060129 INNOVATIVE GYNECOLOGICAL SOLUTIONS LLC IGS VAGINAL SPECULUM 05/04/2006
K132668 IOB MEDICAL INC IOB DISPOSABLE SPECULUM 01/17/2014
K021017 ITL CORPORATION, PTY LTD. LEESPEC DISPOSABLE VAGINAL SPECULUM 06/19/2002
K030761 JIANGSU KAISHOU MEDICAL APPARATUS CO., LTD KAISHOU VAGINAL SPECULUM 06/09/2003
K030693 KENTRON HEALTH CARE, INC. KENTEX DISPOSABLE VAGINAL SPECULUM 08/27/2003
K110766 KOLPLAST CI LTDA KOLPLUX SYSTEM 09/15/2011
K973853 KOLPLAST COMERCIAL E INDUSTRIAL LTDA KOLPLAST VAGINAL SPECULUM 12/19/1997
K092870 KUNSHAN DEYI PLASTIC CO., LTD. NON-STERILE DISPOSABLE VAGINAL SPECULUM 02/16/2010
K000414 MARKETING PERSPECTIVES MEDISUL DISPOSABLE VAGINAL SPECULUM 04/04/2000
K022948 MEDICAL ACTION INDUSTRIES, INC. VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L 11/04/2002
K061339 MEDICAL PRODUCTS DIV. HIERSPEC SPECULUM 09/19/2006
K072942 MEDLINE INDUSTRIES, INC. MEDLINE DISPOSABLE VAGINAL SPECULUM 02/08/2008
K984211 MEDSCAND AB MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 12/23/1998
K963377 NORTH EOS INDUSTRIES, INC. EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC 10/04/1996
K091937 OBP CORPORATION OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM 09/09/2009
K042950 PANATREX, INC. VAG O SPECULUM, MODELS VS1, VM1, VL1 11/30/2004
K991963 PATTON MEDICAL CORP. PATTON SPECULUM 09/01/1999
K971979 PLAYTEX PRODUCTS, INC. PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS 09/26/1997
K000444 PRISM ENTERPRISES, INC. MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM 04/21/2000
K133857 PROA MEDICAL, INC. BRELLA-SPEC(TM) VAGINAL SPECULUM 04/28/2014
K991827 RI MOS. S.R.L. GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 07/19/1999
K013817 SOL WEISS MD INC GLO-SPEC 12/21/2001
K020959 SOL WEISS MD INC GLO-SPEC I, II AND III 06/19/2002
K012859 SOL WEISS MD INC NU-SPEC D 10/26/2001
K002912 STERINC VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 02/21/2001
K021849 TAGG INDUSTRIES TAGG DISPOSABLE VAGINAL SPECULUM 07/16/2002
K983716 VITALCARE GROUP, INC. VITALCARE DISPOSABLE VAGINAL SPECULUM 12/23/1998
K992736 WALLACH SURGICAL DEVICES, INC. WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM 09/29/1999
K070964 WELCH ALLYN, INC. KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM 05/18/2007
K120743 WELCH ALLYN, INC. SPECULUM, VAGINAL, NONMETAL 03/23/2012
K050887 ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY GONGDONG DISPOSABLE VAGINAL SPECULUM 07/11/2005
K052912 ZHEJIANG YUSHENG MEDICAL INSTRUMENT CO. LTD. YUSHENG DISPOSABLE VAGINAL SPECULUM 12/15/2005
K925501 ZINNANTI SURGICAL INSTRUMENTS, INC. NYLON COATED SPECULA 06/13/1997


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