HEX · Class II · 21 CFR 884.1630

FDA Product Code HEX: Colposcope (and Colpomicroscope)

Leading manufacturers include Wallach Surgical Devices, Inc., Lutech Industries, Inc. and Welch Allyn, 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
1–24 of 56
Cleared Jun 14, 2024
Smart Scope® CX
K233043
Periwinkle Technologies Pvt., Ltd.
Obstetrics & Gynecology · 263d
Cleared May 08, 2019
Gynescope System
K190187
Illumigyn , Ltd.
Obstetrics & Gynecology · 96d
Cleared Nov 27, 2018
Biop Digital Colposcope
K182764
Biop Medical , Ltd.
Obstetrics & Gynecology · 60d
Cleared Sep 21, 2018
Pocket Colposcope System
K181034
Hadleigh Health Technologies, LLC
Obstetrics & Gynecology · 156d
Cleared May 21, 2017
LT-300 SD Digital Video Colposcope
K170446
Lutech Industries, Inc.
Obstetrics & Gynecology · 96d
Cleared Dec 19, 2016
EVA (Enhanced Visual Assessment) System
K161871
Mobileodt , Ltd.
Obstetrics & Gynecology · 165d
Cleared Sep 14, 2016
Colposcope System
K160341
Xuzhou Kernel Medical Equipment Co., Ltd.
Obstetrics & Gynecology · 219d
Cleared May 13, 2016
LT-300 HD
K160380
Lutech Industries, Inc.
Obstetrics & Gynecology · 93d
Cleared Dec 01, 2015
Video Colposcope
K151878
Edan Instruments, Inc.
Obstetrics & Gynecology · 145d
Cleared Dec 18, 2014
LT-300 Video Colposcope
K143119
Lutech Industries, Inc.
Obstetrics & Gynecology · 49d
Cleared Oct 23, 2014
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
K140754
CooperSurgical, Inc.
Obstetrics & Gynecology · 211d
Cleared Apr 08, 2014
THE GYNOCULAR
K132423
Gynius AB
Obstetrics & Gynecology · 246d
Cleared Sep 18, 2013
GC-3000E DIGITAL COLPOSCOPE
K122311
Shenzhen Goldcare Meditech Co., Ltd.
Obstetrics & Gynecology · 413d
Cleared Jun 12, 2013
AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
K122973
Medgyn Products, Inc.
Obstetrics & Gynecology · 259d
Cleared Apr 08, 2011
ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE
K110147
Sti Medical Systems, LLC
Obstetrics & Gynecology · 80d
Cleared Mar 10, 2011
DYSIS
K092433
Forth Photonics Hellas SA
Obstetrics & Gynecology · 580d
Cleared Dec 20, 2010
ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY
K090324
Sti Medical Systems
Obstetrics & Gynecology · 679d
Cleared Jul 09, 2010
ECLERIS MICROSTAR COLPOSCOPE
K100595
Ecleris USA
Obstetrics & Gynecology · 129d
Cleared Jan 31, 2008
CERVICAL MD, MODEL C10
K072691
Sti Medical Systems
Obstetrics & Gynecology · 129d
Cleared Nov 15, 2007
COLPO-MASTER
K073053
United Products & Instruments, Inc.
Obstetrics & Gynecology · 16d
Cleared Oct 12, 2007
SOUNMED COLOPOSCOPE COLPO-99/99PLUS
K070845
Sounmed, Inc.
Obstetrics & Gynecology · 199d
Cleared Aug 07, 2006
CO-1000 COLPOSCOPE, MULTIPLE
K061306
Gynex Corp.
Obstetrics & Gynecology · 89d
Cleared Mar 12, 2004
IMAGE MANAGEMENT SYSTEM
K033870
Welch Allyn, Inc.
Obstetrics & Gynecology · 91d
Cleared Oct 26, 1999
TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
K992544
Circon Corp.
Obstetrics & Gynecology · 88d

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.