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HIB — Speculum, Vaginal, Nonmetal Class II

FDA Device Classification

Classification Details

Product Code
HIB
Device Class
Class II
Regulation Number
884.4530
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252208ford medtechJFord Speculum Sleeve™March 6, 2026
K133857proa medicalBRELLA-SPEC(TM) VAGINAL SPECULUMApril 28, 2014
K132668iob medicalIOB DISPOSABLE SPECULUMJanuary 17, 2014
K130046clearspecCLEARSPEC SINGLE USE VAGINAL SPECULUMAugust 6, 2013
K120743welch allynSPECULUM, VAGINAL, NONMETALMarch 23, 2012
K110766kolplast ci ltdaKOLPLUX SYSTEMSeptember 15, 2011
K092870kunshan deyi plastic coNON-STERILE DISPOSABLE VAGINAL SPECULUMFebruary 16, 2010
K091937obp corporationOFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMSeptember 9, 2009
K072942medline industriesMEDLINE DISPOSABLE VAGINAL SPECULUMFebruary 8, 2008
K072762depaltDEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEMJanuary 22, 2008
K070964welch allynKLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEMay 18, 2007
K061339medical products divHIERSPEC SPECULUMSeptember 19, 2006
K060129innovative gynecological solutionsIGS VAGINAL SPECULUMMay 4, 2006
K052420gynovaG-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUMApril 6, 2006
K052192femspecFEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-IFebruary 2, 2006
K052912zhejiang yusheng medical instrument co.YUSHENG DISPOSABLE VAGINAL SPECULUMDecember 15, 2005
K052314dynarexDYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGENovember 9, 2005
K050887zhejiang gongdong medical plastic factoryGONGDONG DISPOSABLE VAGINAL SPECULUMJuly 11, 2005
K041757femspecFEMSPEC DISPOSABLE VAGINAL SPECULUMDecember 23, 2004
K042950panatrexVAG O SPECULUM, MODELS VS1, VM1, VL1November 30, 2004