FDA Product Code HEX: Colposcope (and Colpomicroscope)
Leading manufacturers include Hadleigh Health Technologies, LLC, Biop Medical , Ltd. and Illumigyn , Ltd..
56
Total
56
Cleared
153d
Avg days
1976
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Colposcope (and Colpomicroscope) Devices (Product Code HEX)
56 devices
Cleared
Jun 14, 2024
Smart Scope® CX
Periwinkle Technologies Pvt., Ltd.
Obstetrics & Gynecology
263d
Cleared
May 08, 2019
Gynescope System
Illumigyn , Ltd.
Obstetrics & Gynecology
96d
Cleared
Nov 27, 2018
Biop Digital Colposcope
Biop Medical , Ltd.
Obstetrics & Gynecology
60d
Cleared
Sep 21, 2018
Pocket Colposcope System
Hadleigh Health Technologies, LLC
Obstetrics & Gynecology
156d
About Product Code HEX - Regulatory Context
510(k) Submission Activity
56 total 510(k) submissions under product code HEX since 1976, with 56 receiving FDA clearance (average review time: 153 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.