FDA Product Code HEX: Colposcope (and Colpomicroscope)
Leading manufacturers include Welch Allyn, Inc., CooperSurgical, Inc. and Edan Instruments, Inc..
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
Cleared
Dec 01, 2015
Video Colposcope
Edan Instruments, Inc.
Obstetrics & Gynecology
145d
Cleared
Oct 23, 2014
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
CooperSurgical, Inc.
Obstetrics & Gynecology
211d
Cleared
Mar 12, 2004
IMAGE MANAGEMENT SYSTEM
Welch Allyn, Inc.
Obstetrics & Gynecology
91d
Cleared
Feb 02, 1998
COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM
CooperSurgical, Inc.
Obstetrics & Gynecology
203d
Cleared
May 07, 1996
VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND
Welch Allyn, Inc.
Obstetrics & Gynecology
148d
Cleared
Feb 27, 1989
MALLEABLE PLACENTA CURETTE
Kinetic Medical Products
Obstetrics & Gynecology
35d
Cleared
Feb 23, 1989
JEDMED KP6 COLPOSCOPE
Jedmed Instrument Co.
Obstetrics & Gynecology
87d
Cleared
Oct 23, 1985
OCS-2 COLPOSCOPE
Olympus Corp.
Obstetrics & Gynecology
100d
Cleared
May 20, 1977
COLPOSCOPE SYSTEM
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology
35d
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.