FDA Product Code MOK: Vaginoscope And Accessories
Leading manufacturers include Applied Medical Resources Corporation and KARL STORZ Endoscopy-America, Inc..
2
Total
2
Cleared
146d
Avg days
1995
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Vaginoscope And Accessories Devices (Product Code MOK)
2 devices
Cleared
Sep 16, 2022
GelPOINT V-Path Vaginal Access System
Applied Medical Resources Corporation
Obstetrics & Gynecology
165d
Cleared
Jun 19, 1995
KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology
126d
About Product Code MOK - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code MOK since 1995, with 2 receiving FDA clearance (average review time: 146 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.