FDA.reportPublic FDA data

Uro-V Cystoscope

Primary DI
00860008483713
Brand
Uro-V Cystoscope
Company
UROVIU CORP.
Model
1012
Catalog number
1012
Device description
The Uro-V cystoscope system consists of a multi-use handle with an LCD screen and a single-use cannula. The system is used for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.
Published
2022-12-16
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

Contact Domains#

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
K171500000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171500000Uro-V CystoscopeUroviu Corporation2018-01-30FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008483713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008483713008600084837138600084837130860008483713

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical cystoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. It is used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, to remove tissue samples/stones/small tumours from the bladder, and for removal of the prostate. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length254Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650 397 5174cs@uroviu.com

Regulatory Flags#

DUNS number
118239699
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008483720Uro-N Cystoscope111511152022-12-16
00860008483706Uro-G Flexible Cystoscope152015202022-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
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06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
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