FDA.report

Colposcope

Definition
An electrically-powered instrument intended to be used for the visual examination and treatment of the female genitalia. It is placed directly at the opening of the vagina which is held open with an inserted speculum during colposcopy. The instrument has a light source and magnifying lenses that allow the physician to view the interior of the vagina, particularly the uterine cervix. This device is used to check for cervical cancer typically after an abnormal Papanicolaou test (PAP) or as a follow up procedure to view an abnormal area seen during an earlier gynaecological examination. During colposcopy, samples of tissue can be taken from the cervix for testing.
GUDID devices
166
Last updated
2026-02-09 17:06:36

Related Product Codes

CodeDeviceSpecialtyClassDevices
HEXColposcope (And Colpomicroscope)Obstetrics/Gynecology2150
PTZColposcope (And Colpomicroscope), ExemptObstetrics/Gynecology216
DRCTrocarCardiovascular22
EPTMicroscope, SurgicalGeneral, Plastic Surgery11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
B366U1C200FR01MICROSCOPE ColposcopeEclerisR012024-02-13
B366U1C200TR01MICROSCOPE ColposcopeEclerisR012024-02-13
B366U1C200WR01MICROSCOPE ColposcopeEclerisR012024-02-13
10607151011229BovieASPEN SURGICAL PRODUCTS, INC.CS-103LED2016-08-29
10607151011236BovieASPEN SURGICAL PRODUCTS, INC.CS-103T-DV2016-08-29
10607151011243BovieASPEN SURGICAL PRODUCTS, INC.CS-103T-LED2016-08-29
10607151011267BovieASPEN SURGICAL PRODUCTS, INC.CS-103T-SDV2016-08-29
10607151011281BovieASPEN SURGICAL PRODUCTS, INC.CS-103T-SV2016-08-29
10607151011304BovieASPEN SURGICAL PRODUCTS, INC.CS103T-SVM2016-08-29
10607151011311BovieASPEN SURGICAL PRODUCTS, INC.CS-105LED2016-08-29
10607151011328BovieASPEN SURGICAL PRODUCTS, INC.CS-105T-LED2016-08-29
10607151011335BovieASPEN SURGICAL PRODUCTS, INC.CS-205LED2016-08-29
10607151011342BovieASPEN SURGICAL PRODUCTS, INC.CS-205T-DV2016-08-29
10607151011359BovieASPEN SURGICAL PRODUCTS, INC.CS-205T-LED2016-08-29
10607151011366BovieASPEN SURGICAL PRODUCTS, INC.CS-205T-SDV2016-08-29
10607151011373BovieASPEN SURGICAL PRODUCTS, INC.CS-205T-SV2016-08-29
10607151011380BovieASPEN SURGICAL PRODUCTS, INC.CS205T-SVM2016-08-29
10607151011397BovieASPEN SURGICAL PRODUCTS, INC.CS-3052016-08-29
06944413848542UHD series Video ColposcopeEdan Instruments, Inc.C9A UHD2025-09-05
06944413848559UHD series Video ColposcopeEdan Instruments, Inc.C12A UHD2025-09-05
B366U1C200AR01MICROSCOPE ColposcopeEclerisR012025-07-24
B366U1C200FR02MICROSCOPE ColposcopeEclerisR022025-07-24
B366U1C200TR02MICROSCOPE ColposcopeEclerisR022025-07-24
B366U1C200WR02MICROSCOPE ColposcopeEclerisR022025-07-24
06944413826731UHD series Video ColposcopeEdan Instruments, Inc.C9 UHD2025-06-17
06944413826809UHD series Video ColposcopeEdan Instruments, Inc.C12 UHD2025-06-17
04250365176162ATMOSATMOS MedizinTechnik GmbH & Co. KGi View 21 COLPO2024-11-27
04250365176179ATMOSATMOS MedizinTechnik GmbH & Co. KGi View 31 COLPO2024-11-27
B366HC200AR00MICROSCOPE ColposcopeEclerisR002024-11-27
B366U1C200AR00MICROSCOPE ColposcopeEclerisR002024-11-25
00198506072710ELMED INCORPORATEDELMED INCORPORATEDST9955P2024-10-23
08436041580089OptomicOPTOMIC ESPAÑA SAOP-C12 COLPOSCOPE (45) 2024-07-18
08436041580096OptomicOPTOMIC ESPAÑA SAOP-C16 COLPOSCOPE (45) 2024-07-18
08436041580102OptomicOPTOMIC ESPAÑA SAOP-C5 COLPOSCOPE 2024-07-18
08436041580119OptomicOPTOMIC ESPAÑA SAOP-C2L COLPOSCOPE 2024-07-18
08436041580126OptomicOPTOMIC ESPAÑA SAOP-C2 COLPOSCOPE 2024-07-18
B366U1C200FR00MICROSCOPE ColposcopeEclerisR002024-02-07
B366U1C200TR00MICROSCOPE ColposcopeEclerisR002024-02-07
B366U1C200WR00MICROSCOPE ColposcopeEclerisR002024-02-07
GYNX530LVCDAR0GynexGYNEX CORPORATION530LVCDA-R2023-12-19
GYNX530LVCDAT0GynexGYNEX CORPORATION530LVCDA-T2023-12-19
GYNX530VCDAR0GynexGYNEX CORPORATION530VCDA-R2023-12-19
GYNX530VCDAT0GynexGYNEX CORPORATION530VCDA-T2023-12-19
05060477110263DYSIS ViewDYSIS MEDICAL LIMITEDVIE0012023-12-01
B366MC400MICROSTAR ColposcopeEclerisR022023-08-22
B366MC410MICROSTAR ColposcopeEclerisR002023-08-22
B366C100FHD1MICROSTAR ColposcopeEclerisR002023-08-18
B366U1C100FHD1MICROSTAR ColposcopeEclerisR002023-08-18
08800126000050CervirayAIDOTADT-CC102023-06-14
B366U1C200TRX1MICROSCOPE ColposcopeEclerisRX12022-07-18
B366U1C200WRX1MICROSCOPE ColposcopeEclerisRX12022-07-18
B366U1C200ARX1MICROSCOPE ColposcopeEclerisRX12022-07-18
B366U1C200FRX1MICROSCOPE ColposcopeEclerisRX12022-07-18
B632MDB01039MedibluMedisono, LLCVIDEO COLPOSCOPE DVC200+2022-05-06
B632MDB01038MedibluMEDIBLU MEDICAL LLCDVC 300 HD2020-12-28
B632MDB01036MedibluMEDIBLU MEDICAL LLCDVC 3002020-12-18
B632MDB01013MedibluMEDIBLU MEDICAL LLCDVC 2002020-06-25
00888937000085LEISEGANGCoopersurgical, Inc.OPTIK2-04-0022016-07-29
00888937012996LEISEGANGCoopersurgical, Inc.OPTIK1-002016-07-29
00888937013009LEISEGANGCoopersurgical, Inc.OPTIK1-012016-07-29
00888937013016LEISEGANGCoopersurgical, Inc.OPTIK1-022016-07-29
00888937013023LEISEGANGCoopersurgical, Inc.OPTIK1-032016-07-29
00888937013030LEISEGANGCoopersurgical, Inc.OPTIK2-032016-07-29
00888937013047LEISEGANGCoopersurgical, Inc.OPTIK2-03-0022016-07-29
00888937013054LEISEGANGCoopersurgical, Inc.OPTIK2-042016-07-29
00888937013061LEISEGANGCoopersurgical, Inc.OPTIK2-052016-07-29
00888937013078LEISEGANGCoopersurgical, Inc.OPTIK2-05-0022016-07-29
00888937013085LEISEGANGCoopersurgical, Inc.OPTIK2-06-0052016-07-29
00888937013092LEISEGANGCoopersurgical, Inc.OPTIK2-102016-07-29
00888937013108LEISEGANGCoopersurgical, Inc.OPTIK2-10-0012016-07-29
00888937013115LEISEGANGCoopersurgical, Inc.OPTIK2-112016-07-29
00888937013122LEISEGANGCoopersurgical, Inc.OPTIK2-11-0012016-07-29
00888937013139LEISEGANGCoopersurgical, Inc.OPTIK2-122016-07-29
00888937013146LEISEGANGCoopersurgical, Inc.OPTIK2-12-0012016-07-29
00888937013665WALLACHCoopersurgical, Inc.906043-SP-32016-08-18
00888937013672WALLACHCoopersurgical, Inc.906043-SP-42016-08-18
00888937013689WALLACHCoopersurgical, Inc.906043-SP-52016-08-18
00888937013696WALLACHCoopersurgical, Inc.906043-40TU-52016-08-18
00888937013702WALLACHCoopersurgical, Inc.906057T2016-08-18
00888937013719WALLACHCoopersurgical, Inc.906057-40TU2016-08-18