Product Code: HEX FDA class 2 21 CFR 884.1630

Colposcope (And Colpomicroscope)

Obstetrics/Gynecology

The Colposcope (and Colpomicroscope) is an illuminated magnifying instrument used to closely examine the cervix, vagina, and vulva for signs of disease, particularly in the evaluation of abnormal Pap smear results or visible lesions. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HEX, regulated under 21 CFR 884.1630, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: HEX
Device Class: FDA class 2
Regulation Number: 884.1630
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 56 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K233043	Smart Scope® CX	Jun 14, 2024	Substantially Equivalent	Periwinkle Technologies Pvt. Ltd
K190187	Gynescope System	May 08, 2019	Substantially Equivalent	Illumigyn Ltd.
K182764	Biop Digital Colposcope	Nov 27, 2018	Substantially Equivalent	Biop Medical Ltd.
K181034	Pocket Colposcope System	Sep 21, 2018	Substantially Equivalent	Hadleigh Health Technologies, LLC
K170446	LT-300 SD Digital Video Colposcope	May 21, 2017	Substantially Equivalent	Lutech Industries, Inc.
K161871	EVA (Enhanced Visual Assessment) System	Dec 19, 2016	Substantially Equivalent	MobileODT Ltd.
K160341	Colposcope System	Sep 14, 2016	Substantially Equivalent	XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD
K160380	LT-300 HD	May 13, 2016	Substantially Equivalent	Lutech Industries, Inc.
K151878	Video Colposcope	Dec 01, 2015	Substantially Equivalent	EDAN INSTRUMENTS, INC.
K143119	LT-300 Video Colposcope	Dec 18, 2014	Substantially Equivalent	Lutech Industries, Inc.
K140754	COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM	Oct 23, 2014	Substantially Equivalent	COOPER SURGICAL, INC.
K132423	THE GYNOCULAR	Apr 08, 2014	Substantially Equivalent	GYNIUS AB
K122311	GC-3000E DIGITAL COLPOSCOPE	Sep 18, 2013	Substantially Equivalent	SHENZHEN GOLDCARE MEDITECH CO., LTD.
K122973	AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE	Jun 12, 2013	Substantially Equivalent	MEDGYN PRODUCTS, INC.
K110147	ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE	Apr 08, 2011	Substantially Equivalent	STI MEDICAL SYSTEMS, LLC
K092433	DYSIS	Mar 10, 2011	Substantially Equivalent	FORTH PHOTONICS HELLAS SA
K090324	ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY	Dec 20, 2010	Substantially Equivalent	STI MEDICAL SYSTEMS
K101141	SEILER COLPOSCOPE, MODELS 935, 955 AND 985	Aug 06, 2010	Substantially Equivalent	SEILER PRECISION MICROSCOPES
K100595	ECLERIS MICROSTAR COLPOSCOPE	Jul 09, 2010	Substantially Equivalent	Ecleris USA
K072691	CERVICAL MD, MODEL C10	Jan 31, 2008	Substantially Equivalent	STI MEDICAL SYSTEMS
K073053	COLPO-MASTER	Nov 15, 2007	Substantially Equivalent	UNITED PRODUCTS & INSTRUMENTS, INC.
K070845	SOUNMED COLOPOSCOPE COLPO-99/99PLUS	Oct 12, 2007	Substantially Equivalent	SOUNMED, INC.
K061306	CO-1000 COLPOSCOPE, MULTIPLE	Aug 07, 2006	Substantially Equivalent	GYNEX CORP.
K033870	IMAGE MANAGEMENT SYSTEM	Mar 12, 2004	Substantially Equivalent	WELCH ALLYN, INC.
K031436	MEDISCOPE	Dec 19, 2003	Substantially Equivalent	SOMETECH CORPORATION
K031639	INTERMED ZOOM COLPOSCOPE	Aug 22, 2003	Substantially Equivalent	INTERMED GROUP, INC.
K021153	GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000	Feb 10, 2003	Substantially Equivalent	GOLDWAY US, INC.
K021854	DFV CPG COLPOSCOPE	Oct 25, 2002	Substantially Equivalent	D.F. VASCONCELLOS S.A.
K001314	MEDSCOPE	Jul 25, 2000	Substantially Equivalent	ALL-PRO IMAGING CORP.
K000707	LEICA COLPOSCOPE	Jun 27, 2000	Substantially Equivalent	LEICA MICROSCOPY SYSTEMS LTD.
K992544	TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM	Oct 26, 1999	Substantially Equivalent	CIRCON CORP.
K981958	LEISEGANG VIDEO COLPOSCOPE	Oct 19, 1998	Substantially Equivalent	NETOPTIX CORP.
K972630	COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM	Feb 02, 1998	Substantially Equivalent	COOPERSURGICAL, INC.
K963593	IMT LOUPE-COLPOSCOPE	Apr 22, 1997	Substantially Equivalent	INVENTIVE MEDICAL TECHNOLOGY
K955635	VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND	May 07, 1996	Substantially Equivalent	WELCH ALLYN, INC.
K940094	COLPOSCOPES AND ACCESSORIES	Apr 25, 1995	Substantially Equivalent	LEISEGANG MEDICAL, INC.
K932896	HM-0690 COLPOSCOPE	Mar 23, 1994	Substantially Equivalent	HILL-MED, INC.
K932782	HM-0660	Mar 23, 1994	Substantially Equivalent	HILL-MED, INC.
K913365	ACCUSCOPE(TM) & ACCUSCOPE II(TM)	Apr 27, 1992	Substantially Equivalent	VINELAND MEDICAL PRODUCTS, INC.
K902313	LM-1Z ZOOM SCOPE	Sep 04, 1990	Substantially Equivalent	LEISEGANG MEDICAL, INC.
K903213	ARTHROSCOPIC SURGICAL KNIVES MODELS 1001 AND 1002	Jul 27, 1990	Substantially Equivalent	PERCUTANEOUS TECHNOLOGIES
K890387	MALLEABLE PLACENTA CURETTE	Feb 27, 1989	Substantially Equivalent	KINETIC MEDICAL PRODUCTS
K884934	JEDMED KP6 COLPOSCOPE	Feb 23, 1989	Substantially Equivalent	JEDMED INSTRUMENT CO.
K880195	GYNESCOPE	Mar 14, 1988	Substantially Equivalent	MEDGYN PRODUCTS, INC.
K871683	COLPOSTAR V-6	Aug 05, 1987	Substantially Equivalent	WALLACH SURGICAL DEVICES, INC.
K871681	PHOTOSTAR V-8	Aug 05, 1987	Substantially Equivalent	WALLACH SURGICAL DEVICES, INC.
K871682	WALLACH CONVERTIBLE COLPOSCOPE	Jun 24, 1987	Substantially Equivalent	WALLACH SURGICAL DEVICES, INC.
K853389	WALLACH ZOOM COLPOSCOPE	Nov 19, 1985	Substantially Equivalent	WALLACH SURGICAL DEVICES, INC.
K852980	OCS-2 COLPOSCOPE	Oct 23, 1985	Substantially Equivalent	OLYMPUS CORP.
K821616	CERVISCOPE OPTICAL SYSTEM	Jun 16, 1982	Substantially Equivalent	FOTOMEDICS, INC.
K801730	KRYMED SYSTEM 4001 TILT SCOPE	Aug 13, 1980	Substantially Equivalent	CRYOMEDICS, INC.
K791279	KOLPOSKOP KP20005	Sep 17, 1979	Substantially Equivalent	ELMED, INC.
K770896	COLPOSCOPE MODEL II	Jun 03, 1977	Substantially Equivalent	DYNATECH CRYOMEDICAL CO.
K770697	COLPOSCOPE SYSTEM	May 20, 1977	Substantially Equivalent	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K761205	DYNATECH JD7/JD7P COLPOSCOPE	Dec 17, 1976	Substantially Equivalent	DYNATECH CRYOMEDICAL CO.
K760763	COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I	Oct 20, 1976	Substantially Equivalent	DYNATECH CRYOMEDICAL CO.

FEI Numbers

This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.

1216677: 233 registrations

1316463: 77 registrations

1450908: 62 registrations

1927430: 5 registrations

3000200590: 8 registrations

3001238683: 44 registrations

3002807462: 1 registration

3003969012: 8 registrations

3005216736: 18 registrations

3006179052: 13 registrations

3006667212: 1 registration

3007532396: 21 registrations

3008393409: 12 registrations

3009201600: 4 registrations

3010023733: 3 registrations

3010390940: 22 registrations

3010395077: 5 registrations

3014982233: 1 registration

3016250458: 1 registration

3016860442: 33 registrations

3016965604: 1 registration

3017221021: 4 registrations

3035387162: 15 registrations

3036423383: 2 registrations