Product code MOK— Obstetrics/Gynecology

GelPOINT V-Path Vaginal Access System

Classification name
Vaginoscope And Accessories
Device class
Class 2
Regulation
21 CFR 884.1630
Advisory panel
Obstetrics/Gynecology
Total cleared
2
First cleared
Most recent

Market context for product code MOK

FDA has cleared 2 devices under product code MOK between 1995 and 2022, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code MOK

Recent clearances under product code MOK

Data sourced from openFDA. This site is unofficial and independent of the FDA.