FDA.reportPublic FDA data

Sheath Section

Primary DI
04953170062445
Brand
Sheath Section
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-655
Device description
"""MAJ-655 FLEXCYSTO NEEDLE SHEATH"""
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
FAJCystoscope and accessories, flexible/rigid
FGAKit, nephroscope
KGEFORCEPS, BIOPSY, ELECTRIC
KNSUnit, electrosurgical, endoscopic (with or without accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FGAKit, NephroscopeGastroenterology, Urology2
KGEForceps, Biopsy, ElectricGastroenterology, Urology2
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993041000OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENTThe Olympus Optical Co.2000-03-30FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170062445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170062445049531700624454953170062445

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, reusableA flexible sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170025693P CORDMAJ-348125002016-09-21
04953170048548A CORDMH-9692016-09-21
04953170062872A CORDMAJ-8602016-09-21
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00191506062521Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062521Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
00191506062538Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062538Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
00191506062545Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
00191506062545Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062552Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
00191506062552Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062569Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062569Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
00191506062576Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062576Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
00191506062583Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062583Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
00191506062590Navigator™BOSTON SCIENTIFIC CORPORATIONFGA2026-09-25
00191506062590Navigator™BOSTON SCIENTIFIC CORPORATIONFAJ2026-09-25
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06975339621926BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
00850023925442WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925459WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925466WiScope®Otu Medical Inc.FAJ2026-07-28