FDA.reportPublic FDA data

WiScope®

Primary DI
00850023925190
Brand
WiScope®
Company
Otu Medical Inc.
Model
OTU-C310R
Device description
Single-Use Digital Flexible Cystoscope
Published
2022-04-18
Public version status
Update
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
10850023925197PackageGS110In Commercial Distribution
20850023925194PackageGS12In Commercial Distribution
30850023925191PackageGS110In Commercial Distribution
00850023925190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002392519710850023925197
2085002392519420850023925194
3085002392519130850023925191
00850023925190008500239251908500239251900850023925190

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
00850023925442WiScope®OTU-C380SL (OTU-300S)2026-07-28
00850023925459WiScope®OTU-C380RL (OTU-C300R)2026-07-28
00850023925466WiScope®OTU-C380SR (OTU-C310S)2026-07-28
00850023925473WiScope®OTU-C380RR (OTU-C310R)2026-07-28
00850023925558WiScope®OTU-T Pro4202T1101T2026-07-28
00850023925565WiScope®OTU-C320S2026-07-28
00850023925572WiScope®OTU-C320R2026-07-28
00850023925589WiScope®OTU-C330S2026-07-28
00850023925596WiScope®OTU-C330R2026-07-28
00850023925602WiScope®OTU-140R2026-07-28
00850023925619WiScope®OTU-140S2026-07-28
00850023925626WiScope®OTU-110R2026-07-28
00850023925633WiScope®OTU-110S2026-07-28
00850023925640WiScope®OTU-130R2026-07-28
00850023925657WiScope®OTU-130S2026-07-28
00850023925909WiScope®OTU-CK320S2026-07-28
00850023925916WiScope®OTU-CK320R2026-07-28
00850023925923WiScope®OTU-CK330S2026-07-28
00850023925930WiScope®OTU-CK330R2026-07-28
00850023925954WiScope®OTU-T Pro4202T1201T2026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826926952PENTAX MedicalPENTAX MEDICAL CORPORATIONFAJ2026-08-25
06975339621506BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621513BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621520BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
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
00850023925473WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925558WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925565WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925572WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925589WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925596WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925909WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925916WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925923WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925930WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925954WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925985WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925992WiScope®Otu Medical Inc.FAJ2026-07-28
06972084140498WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140504WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140511WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140528WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140597WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28