FDA.reportPublic FDA data

Olympus

Primary DI
04042761006101
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
A4215A
Catalog number
A4215A
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

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (Flexible Or Rigid)
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K944072000
K950076000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K944072000OLYMPUS NASAL AND SINUS ENDOSCOPESOlympus America, Inc.1995-01-11EOB
K950076000LAPAROSCOPEOlympus America, Inc.1995-03-03GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042761006101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042761006101040427610061014042761006101

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope camera adaptorAn optical device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. It may be referred to as a coupler. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316957240
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042761082297OlympusWA03300AWA03300A2016-09-22
04042761082303OlympusWA03310AWA03310A2016-09-22
14042761083369OlympusWT645010WT6450102023-06-20
04042761083324OlympusWT806450WT8064502023-01-27
04042761081757OlympusWA97013AWA97013A2023-06-20
04042761083102OlympusWT2187002023-06-20
04042761083119OlympusWT2187052023-06-20
04042761083126OlympusWT2187112023-06-20
04042761083133OlympusWT2187202023-06-20
04042761083140OlympusWT6304002023-06-20
04042761083164OlympusWT6400212023-06-20
04042761083171OlympusWT645001WT6450012023-06-20
04042761083188OlympusWT645006WT6450062023-06-20
04042761083218OlympusWT645013WT6450132023-06-20
04042761083225OlympusWT645016WT6450162023-06-20
04042761083232OlympusWT645017WT6450172023-06-20
04042761083256OlympusWT645020WT6450202023-06-20
04042761083263OlympusWT645025WT6450252023-06-20
04042761083270OlympusWT645030WT6450302023-06-20
04042761083287OlympusWT645031WT6450312023-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826921001PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921056PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921063PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921070PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921117PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921148PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826922473PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826922497PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925719PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925726PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925948VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925979PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926006VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926174PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926181PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926310PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926327PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926358PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926433PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926440PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926457PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926617PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826927034PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826927041PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25