MOK — Vaginoscope And Accessories Class II

FDA Device Classification

FDA product code MOK covers "Vaginoscope And Accessories", a Class II medical device regulated under 21 CFR 884.1630. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MOK
Device Class
Class II
Regulation Number
884.1630
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K220969applied medical resources corporationGelPOINT V-Path Vaginal Access SystemSeptember 16, 2022
K950639karl storz endoscopy-americaKARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CAJune 19, 1995