KXP — Stent, Vaginal Class II

FDA Device Classification

FDA product code KXP covers "Stent, Vaginal", a Class II medical device regulated under 21 CFR 884.3900. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KXP
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
K202542pmt corporationAllura Vaginal StentSeptember 30, 2020
K983045owen mumford usaAMIELLENovember 25, 1998
K974479silimedSILIMED VAGINAL STENTAugust 5, 1998
K920633bioteque americaPESSARY FLEXIBLE SILICONE NICHOLSNovember 8, 1995