FDA.reportPublic FDA data

WiScope®

Primary DI
00850023925916
Brand
WiScope®
Company
Otu Medical Inc.
Model
OTU-CK320R
Device description
Single-Use Digital Flexible Cystoscope
Published
2026-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K231702000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
10850023925913PackageGS12In Commercial Distribution
20850023925910PackageGS110In Commercial Distribution
00850023925916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002392591310850023925913
2085002392591020850023925910
00850023925916008500239259168500239259160850023925916

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00850023925923WiScope®OTU-CK330S2026-07-28
00850023925930WiScope®OTU-CK330R2026-07-28
00850023925954WiScope®OTU-T Pro4202T1201T2026-07-28
00850023925978AptraBDRD022026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
06972084140603WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140610AptraNingbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140627AptraNingbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140665WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140672WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140689WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140696WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
00848657078450AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-22
00810143893137Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893144Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21