FDA.reportPublic FDA data

SINGLE USE DISTAL COVER

Primary DI
04953170467370
Brand
SINGLE USE DISTAL COVER
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-2315
Catalog number
N6192001
Published
2026-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDTDuodenoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDTDuodenoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253646000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253646000Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp.2026-02-22FDT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170467377PackageGS120In Commercial Distribution
04953170467370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317046737714953170467377
04953170467370049531704673704953170467370

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope patient protection cap, single-useAn invasive device, typically in the form of a detachable cap, designed to cover the exposed mechanical components at the distal end of an endoscope (e.g., duodenoscope) during an endoscopic procedure to protect the patient from injury. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
Lot or batch
true
Expiration 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
04580826921391PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826921407PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826921438PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826926693PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826926709PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826926778PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826926792PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826928406PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826928499PENTAX MedicalPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826930935INSPIRAPENTAX MEDICAL CORPORATIONFDT2026-08-25
04580826930959INSPIRAPENTAX MEDICAL CORPORATIONFDT2026-08-25
14953170467377SINGLE USE DISTAL COVEROLYMPUS MEDICAL SYSTEMS CORP.FDT2026-03-06
04961333255801INSPIRAHOYA CORPORATIONFDT2025-06-20
04961333255825INSPIRAHOYA CORPORATIONFDT2025-06-20
05707480157167Ambu® aScope™ Duodeno 2Ambu A/SFDT2025-03-29
04961333356355PENTAX MedicalHOYA CORPORATIONFDT2024-09-03
04961333356331PENTAX MedicalHOYA CORPORATIONFDT2024-09-03
05707480157143Ambu® aScope™ Duodeno 2Ambu A/SFDT2024-07-19
05707480157136Ambu® aScope™ Duodeno 2Ambu A/SFDT2024-07-19
04961333254910INSPIRAHOYA CORPORATIONFDT2023-12-01
04961333247974INSPIRAHOYA CORPORATIONFDT2023-09-16
14961333232960PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
14961333232991PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
14961333246233PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04961333084456PENTAXHOYA CORPORATIONFDT2023-07-31
04961333084470PENTAXHOYA CORPORATIONFDT2023-07-31
04961333232963PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04961333232994PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04961333246236PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04953170438066Air/water valveOLYMPUS MEDICAL SYSTEMS CORP.FDT2023-04-22