FDA.reportPublic FDA data

EVIS EXERA II XENON LIGHT SOURCE

Primary DI
04953170216961
Brand
EVIS EXERA II XENON LIGHT SOURCE
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
CLV-180
Catalog number
N2277253
Published
2021-12-17
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
EOBNasopharyngoscope (Flexible Or Rigid)
EOQBronchoscope (Flexible Or Rigid)
FDFColonoscope And Accessories, Flexible/Rigid
FDSGastroscope And Accessories, Flexible/Rigid
GCTLight Source, Endoscope, Xenon Arc
NWBEndoscope, Accessories, Narrow Band Spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
GCTLight Source, Endoscope, Xenon ArcGastroenterology, Urology2
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061313000
K133538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061313000EVIS EXERA 180 SYSTEMOlympus Medical Systems Corporation2006-08-31EOQ
K133538000VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NEOlympus Corporation of the Americas2014-08-07NWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170216961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170216961049531702169614953170216961

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source unit, line-poweredA mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

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
04953170421594HD CAMERA HEADCH-S200-08-LBN61317402026-07-22
04953170459207Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8019N62211302025-12-02
04953170459252Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8022N62213302025-12-02
04953170459313Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8025N62215302025-12-02
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04961333246779PENTAXHOYA CORPORATIONFDF2025-04-04
04961333246830PENTAXHOYA CORPORATIONFDF2025-04-04
04961333246847PENTAXHOYA CORPORATIONFDS2025-04-04
04961333246939PENTAXHOYA CORPORATIONFDS2025-04-04
04961333239825VIVIDEOHOYA CORPORATIONEOB2024-02-07
04961333251650PENTAX MedicalHOYA CORPORATIONFDF2023-10-31
04961333251650PENTAX MedicalHOYA CORPORATIONFDS2023-10-31
04961333252145PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333251827PENTAX MedicalHOYA CORPORATIONFDS2023-09-20
04961333251827PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333251834PENTAX MedicalHOYA CORPORATIONFDS2023-09-20
04961333251834PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333251841PENTAX MedicalHOYA CORPORATIONFDS2023-09-20
04961333251841PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333252107PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333252107PENTAX MedicalHOYA CORPORATIONFDS2023-09-20
04961333252114PENTAX MedicalHOYA CORPORATIONFDF2023-09-20
04961333252114PENTAX MedicalHOYA CORPORATIONFDS2023-09-20
04961333075157PENTAXHOYA CORPORATIONFDS2023-09-15
04961333075157PENTAXHOYA CORPORATIONFDF2023-09-15
04961333084753PENTAXHOYA CORPORATIONEOQ2023-07-31
04961333070367PENTAXHOYA CORPORATIONEOB2023-07-31
04961333070466PENTAXHOYA CORPORATIONFDS2023-07-31
04961333070541PENTAXHOYA CORPORATIONEOQ2023-07-31
04961333071043PENTAXHOYA CORPORATIONFDS2023-07-31
04961333071357PENTAXHOYA CORPORATIONFDS2023-07-31
04961333075164PENTAXHOYA CORPORATIONEOB2023-07-31
04961333077731PENTAXHOYA CORPORATIONFDS2023-07-31
04961333077984PENTAXHOYA CORPORATIONEOB2023-07-31
04961333083015PENTAXHOYA CORPORATIONEOQ2023-07-31