Atlas FDA

HEX

56 FDA 510(k) clearances · Product code

104 daysmedian time to decision
287 days90th percentile
56clearances measured

FDA profile

Official device name
Colposcope (And Colpomicroscope)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1630
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Smart Scope® CX (K233043)Periwinkle Technologies Pvt., Ltd.2024-06-14
Gynescope System (K190187)Illumigyn , Ltd.2019-05-08
Biop Digital Colposcope (K182764)Biop Medical , Ltd.2018-11-27
Pocket Colposcope System (K181034)Hadleigh Health Technologies, LLC2018-09-21
LT-300 SD Digital Video Colposcope (K170446)Lutech Industries, Inc.2017-05-21
EVA (Enhanced Visual Assessment) System (K161871)Mobileodt , Ltd.2016-12-19
Colposcope System (K160341)Xuzhou Kernel Medical Equipment Co., Ltd.2016-09-14
LT-300 HD (K160380)Lutech Industries, Inc.2016-05-13
Video Colposcope (K151878)Edan Instruments, Inc.2015-12-01
LT-300 Video Colposcope (K143119)Lutech Industries, Inc.2014-12-18
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM (K140754)CooperSurgical, Inc.2014-10-23
THE GYNOCULAR (K132423)Gynius AB2014-04-08
GC-3000E DIGITAL COLPOSCOPE (K122311)Shenzhen Goldcare Meditech Co., Ltd.2013-09-18
AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE (K122973)Medgyn Products, Inc.2013-06-12
ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE (K110147)Sti Medical Systems, LLC2011-04-08
DYSIS (K092433)Forth Photonics Hellas SA2011-03-10
ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY (K090324)Sti Medical Systems2010-12-20
SEILER COLPOSCOPE, MODELS 935, 955 AND 985 (K101141)Seiler Precision Microscopes2010-08-06
ECLERIS MICROSTAR COLPOSCOPE (K100595)Ecleris USA2010-07-09
CERVICAL MD, MODEL C10 (K072691)Sti Medical Systems2008-01-31
COLPO-MASTER (K073053)United Products & Instruments, Inc.2007-11-15
SOUNMED COLOPOSCOPE COLPO-99/99PLUS (K070845)Sounmed, Inc.2007-10-12
CO-1000 COLPOSCOPE, MULTIPLE (K061306)Gynex Corp.2006-08-07
IMAGE MANAGEMENT SYSTEM (K033870)Welch Allyn, Inc.2004-03-12
MEDISCOPE (K031436)Sometech Corporation2003-12-19
INTERMED ZOOM COLPOSCOPE (K031639)Intermed Group, Inc.2003-08-22
GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000 (K021153)Goldway Us, Inc.2003-02-10
DFV CPG COLPOSCOPE (K021854)D.F. Vasconcellos S.A.2002-10-25
MEDSCOPE (K001314)All-Pro Imaging Corp.2000-07-25
LEICA COLPOSCOPE (K000707)Leica Microscopy Systems , Ltd.2000-06-27
TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM (K992544)Circon Corp.1999-10-26
LEISEGANG VIDEO COLPOSCOPE (K981958)Netoptix Corp.1998-10-19
COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM (K972630)CooperSurgical, Inc.1998-02-02
IMT LOUPE-COLPOSCOPE (K963593)Inventive Medical Technology1997-04-22
VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND (K955635)Welch Allyn, Inc.1996-05-07
COLPOSCOPES AND ACCESSORIES (K940094)Leisegang Medical, Inc.1995-04-25
HM-0660 (K932782)Hill-Med, Inc.1994-03-23
HM-0690 COLPOSCOPE (K932896)Hill-Med, Inc.1994-03-23
ACCUSCOPE(TM) & ACCUSCOPE II(TM) (K913365)Vineland Medical Products, Inc.1992-04-27
LM-1Z ZOOM SCOPE (K902313)Leisegang Medical, Inc.1990-09-04
ARTHROSCOPIC SURGICAL KNIVES MODELS 1001 AND 1002 (K903213)Percutaneous Technologies1990-07-27
MALLEABLE PLACENTA CURETTE (K890387)Kinetic Medical Products1989-02-27
JEDMED KP6 COLPOSCOPE (K884934)Jedmed Instrument Co.1989-02-23
GYNESCOPE (K880195)Medgyn Products, Inc.1988-03-14
PHOTOSTAR V-8 (K871681)Wallach Surgical Devices, Inc.1987-08-05
COLPOSTAR V-6 (K871683)Wallach Surgical Devices, Inc.1987-08-05
WALLACH CONVERTIBLE COLPOSCOPE (K871682)Wallach Surgical Devices, Inc.1987-06-24
WALLACH ZOOM COLPOSCOPE (K853389)Wallach Surgical Devices, Inc.1985-11-19
OCS-2 COLPOSCOPE (K852980)Olympus Corp.1985-10-23
CERVISCOPE OPTICAL SYSTEM (K821616)Fotomedics, Inc.1982-06-16
KRYMED SYSTEM 4001 TILT SCOPE (K801730)Cryomedics, Inc.1980-08-13
KOLPOSKOP KP20005 (K791279)Elmed, Inc.1979-09-17
COLPOSCOPE MODEL II (K770896)Dynatech Cryomedical Co.1977-06-03
COLPOSCOPE SYSTEM (K770697)Richard Wolf Medical Instruments Corp.1977-05-20
DYNATECH JD7/JD7P COLPOSCOPE (K761205)Dynatech Cryomedical Co.1976-12-17
COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I (K760763)Dynatech Cryomedical Co.1976-10-20

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