FDA.reportPublic FDA data

Stand

Primary DI
04953170331695
Brand
Stand
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
OCS5-STD
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HEXCOLPOSCOPE (AND COLPOMICROSCOPE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEXColposcope (And Colpomicroscope)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K852980000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K852980000OCS-2 COLPOSCOPEOlympus Corp.1985-10-23HEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170331695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170331695049531703316954953170331695

GMDN Terms#

Term, Definition table
TermDefinition
ColposcopeAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06
04953170235030SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cmT39152017-10-06
04953170235122SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cmT39302017-10-06
04953170235153SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cmT39352017-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B366U1C200AR01MICROSCOPE ColposcopeEclerisHEX2025-07-24
B366U1C200FR02MICROSCOPE ColposcopeEclerisHEX2025-07-24
B366U1C200TR02MICROSCOPE ColposcopeEclerisHEX2025-07-24
B366U1C200WR02MICROSCOPE ColposcopeEclerisHEX2025-07-24
B366HC200AR00MICROSCOPE ColposcopeEclerisHEX2024-11-27
B366U1C200AR00MICROSCOPE ColposcopeEclerisHEX2024-11-25
B366U1C200FR01MICROSCOPE ColposcopeEclerisHEX2024-02-13
B366U1C200TR01MICROSCOPE ColposcopeEclerisHEX2024-02-13
B366U1C200WR01MICROSCOPE ColposcopeEclerisHEX2024-02-13
B366U1C200FR00MICROSCOPE ColposcopeEclerisHEX2024-02-07
B366U1C200TR00MICROSCOPE ColposcopeEclerisHEX2024-02-07
B366U1C200WR00MICROSCOPE ColposcopeEclerisHEX2024-02-07
GYNX530LVCDAR0GynexGYNEX CORPORATIONHEX2023-12-19
GYNX530LVCDAT0GynexGYNEX CORPORATIONHEX2023-12-19
GYNX530VCDAR0GynexGYNEX CORPORATIONHEX2023-12-19
GYNX530VCDAT0GynexGYNEX CORPORATIONHEX2023-12-19
05060477110263DYSIS ViewDYSIS MEDICAL LIMITEDHEX2023-12-01
B366MC400MICROSTAR ColposcopeEclerisHEX2023-08-22
B366MC410MICROSTAR ColposcopeEclerisHEX2023-08-22
B366C100FHD1MICROSTAR ColposcopeEclerisHEX2023-08-18
B366U1C100FHD1MICROSTAR ColposcopeEclerisHEX2023-08-18
B366U1C200TRX1MICROSCOPE ColposcopeEclerisHEX2022-07-18
B366U1C200WRX1MICROSCOPE ColposcopeEclerisHEX2022-07-18
B366U1C200ARX1MICROSCOPE ColposcopeEclerisHEX2022-07-18
B366U1C200FRX1MICROSCOPE ColposcopeEclerisHEX2022-07-18
B632MDB01039MedibluMedisono, LLCHEX2022-05-06
B632MDB01038MedibluMEDIBLU MEDICAL LLCHEX2020-12-28
B632MDB01036MedibluMEDIBLU MEDICAL LLCHEX2020-12-18
57290018240026Gynescope, console systemILLUMIGYN LTDHEX2020-11-26
67290018240016Gynescope Image acquistion systemILLUMIGYN LTDHEX2020-11-26