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HDX — Dilator, Vaginal Class II

FDA Device Classification

Classification Details

Product Code
HDX
Device Class
Class II
Regulation Number
884.3900
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241748plus ev holdings dba intimate roseIntimate Rose Vaginal DilatorsAugust 14, 2024
K233689lujenaHope&Her Vaginal DilatorsMay 2, 2024
K222492lujenaHope&Her Vaginal DilatorsJune 27, 2023
K231430plus ev holdings dba intimate roseIntimate Rose Vaginal DilatorsJune 7, 2023
K220035materna medicalMilli Vaginal DilatorFebruary 27, 2023
K211959materna medicalMilli Vaginal DilatorDecember 1, 2021
K130273panpac medical corporationPANPAC VAGINAL DILATORSAugust 8, 2013
K071754karl storz endoscopy-americaNEO-VAGINA SURGERY SET AND ACCESSORIESJanuary 7, 2009
K003380bioteque americaBIOTEQUE VAGINAL DILATORJanuary 29, 2001