FDA.reportPublic FDA data

WiScope®

Primary DI
00850023925282
Brand
WiScope®
Company
Otu Medical Inc.
Model
OTU-A
Catalog number
4201A0501T
Device description
Image System, adapting to a monitor of 16:9 aspect ratio
Published
2023-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid
FGBUreteroscope And Accessories, Flexible/Rigid

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181977000WiScope Digital Endoscope SystemOTU Medical, Inc.2018-08-14FGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850023925282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850023925282008500239252828500239252820850023925282

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
100796993
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850023925237WiScope®OTU-OM100SR2023-04-30
00850023925244WiScope®OTU-OM100RR2023-04-30
00850023925251WiScope®OTU-OM100SL2023-04-30
00850023925268WiScope®OTU-OM100RL2023-04-30
00850023925299WiScope®OTU-OM100S2023-04-30
00850023925305WiScope®OTU-OM100R2023-04-30
00850023925381AptraBDCYSD012024-09-30
00850023925398AptraBDCYRD012024-09-30
00850023925428WiScope®OTU-C311S2024-09-30
00850023925435WiScope®OTU-C311R2024-09-30
10850023925388AptraBDCYSD012024-09-30
10850023925395AptraBDCYRD012024-09-30
10850023925425WiScope®OTU-C311S2024-09-30
10850023925432WiScope®OTU-C311R2024-09-30
00850023925169WiScope®OTU-C300S2022-04-18
00850023925176WiScope®OTU-C300R2022-04-18
00850023925183WiScope®OTU-C310S2022-04-18
00850023925190WiScope®OTU-C310R2022-04-18
00850023925329WiScope®OTU-120R4101U0601T2024-01-12
00850023925336WiScope®OTU-120S4101U0501T2024-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840432200001CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00840432200018CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00810116023387Dornier Axis IIDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023400Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023424Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAJ2026-05-06
00810116023578Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
10810068811046MONARCH™Platform, UrologyAuris Health, Inc.FGB2026-05-05
10810068811053Monarch® Ureteroscopy KitAuris Health, Inc.FGB2026-05-05
10810068811107MONARCH™ Urology Irrigation CartridgeAuris Health, Inc.FGB2026-05-04
10810068811121MONARCH™ Ureteroscope ValveAuris Health, Inc.FGB2026-05-04
00810116024056Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024070Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024094Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024117Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
08881300750107F88SG ENDOSCOPY PTE. LTD.FGB2025-06-30
00850023925381AptraOtu Medical Inc.FAJ2024-09-30
00850023925398AptraOtu Medical Inc.FAJ2024-09-30
00850023925428WiScope®Otu Medical Inc.FAJ2024-09-30
00850023925435WiScope®Otu Medical Inc.FAJ2024-09-30
00677964074936ENDO SMARTCAPMEDIVATORS INC.FAJ2024-05-29
07613327616675SPYSTRYKER CORPORATIONFAJ2024-02-27
07613327616736SPYSTRYKER CORPORATIONFAJ2024-02-27
00850023925329WiScope®Otu Medical Inc.FGB2024-01-12
00850023925336WiScope®Otu Medical Inc.FGB2024-01-12
10818634025149AmbuBosma EnterprisesFAJ2023-05-01
10818634025194AmbuBosma EnterprisesFAJ2023-05-01
00850023925237WiScope®Otu Medical Inc.FGB2023-04-30
00850023925244WiScope®Otu Medical Inc.FGB2023-04-30
00850023925251WiScope®Otu Medical Inc.FGB2023-04-30
00850023925268WiScope®Otu Medical Inc.FGB2023-04-30