FDA.reportPublic FDA data

Aptra

Primary DI
00850023925381
Brand
Aptra
Company
Otu Medical Inc.
Model
BDCYSD01
Device description
Aptra Single-Use Digital Flexible Cystoscope
Published
2024-09-30
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

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212202000
K231702000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212202000WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image SystemOTU Medical, Inc.2022-04-13FAJ
K231702000WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical TabletOTU Medical, Inc.2023-09-29FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850023925388PackageGS12In Commercial Distribution
20850023925385PackageGS110In Commercial Distribution
00850023925381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002392538810850023925388
2085002392538520850023925385
00850023925381008500239253818500239253810850023925381

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video cystoscope, single-useA sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a single-use device.

Regulatory Flags#

DUNS number
100796993
Device count
1
Lot or batch
true
Expiration 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
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
00850023925312WiScope®OTU-T4202T0101T2024-01-12

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
00810116023424Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAJ2026-05-06
00850023925398AptraOtu Medical Inc.FAJ2024-09-30
00850023925428WiScope®Otu Medical Inc.FAJ2024-09-30
00850023925435WiScope®Otu Medical Inc.FAJ2024-09-30
04055207038512RIWORichard Wolf GmbHFAJ2024-08-19
04055207008607NARichard Wolf GmbHFAJ2024-08-19
00677964074936ENDO SMARTCAPMEDIVATORS INC.FAJ2024-05-29
07613327616675SPYSTRYKER CORPORATIONFAJ2024-02-27
07613327616736SPYSTRYKER CORPORATIONFAJ2024-02-27
10818634025149AmbuBosma EnterprisesFAJ2023-05-01
10818634025194AmbuBosma EnterprisesFAJ2023-05-01
50724995219241ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219258ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219265ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219272ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
00848657076135AED Flexible Cystoscopy Biopsy Forcep, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076142AED Flexible Cystoscopy Alligator Forcep S/A, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076159AED Flexible Cystoscopy Alligator Forcep D/A, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076166AED Flexible Cystoscopy Rat Tooth Forcep, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00860008483706Uro-G Flexible CystoscopeUROVIU CORP.FAJ2022-12-16
00850006759668Aveta Auto 5 Fr Disposable Resecting DeviceMEDITRINA, INC.FAJ2022-08-18
00850023925169WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925176WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925183WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925190WiScope®Otu Medical Inc.FAJ2022-04-18
00853277008084LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FAJ2021-08-13
00853277008091LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FAJ2021-08-13
00851545007555ProsurgPROSURG INCFAJ2020-05-21