FDA.reportPublic FDA data

SPARE FUSE

Primary DI
04953170214523
Brand
SPARE FUSE
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-1432
Device description
MAJ-1432 SPARE FUSE EVIS EXERA II
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDFColonoscope and accessories, flexible/rigid
FDSGastroscope and accessories, flexible/rigid
NWBEndoscope, accessories, narrow band spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051645000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051645000EVIS EXERA 160A SYSTEMOlympus Medical Systems Corporation2005-10-13NWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170214523PrimaryGS10
84953170214529Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170214523049531702145234953170214523
8495317021452984953170214529

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source, line-poweredA mains electricity (AC-powered), typically bench-top unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes (e.g., arthroscopes, cystoscopes, laparoscopes, gastroscopes). It provides 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
2
Lot or batch
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
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920066PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920066PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920271PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920271PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920295PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920325PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920394PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920462PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920660PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
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04580826921278PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
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04580826921599PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921742PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921759PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921865PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921940PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921957PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826922176PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922183PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922190PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826925832PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25