Uro-N Cystoscope

FDA UDI

Class II (US FDA UDI)

by UroViu Corporation

Identity

Trade Name: Uro-N Cystoscope FDA UDI
Generic Name: Rigid optical cystoscope FDA UDI
Device Name: The Uro-N cystoscope system consists of a mulit-use handle with an LCD screeen and a single-use sterile cannula. The Uro-N is intended fr directed injection of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope. FDA UDI
Model / Reference: 1115 FDA UDI
Description: The Uro-N cystoscope system consists of a mulit-use handle with an LCD screeen and a single-use sterile cannula. The Uro-N is intended fr directed injection of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope. FDA UDI

Identifiers

Catalog Number: 1115 FDA UDI
Primary DI / UDI-DI: 00860008483720 FDA UDI
510(k) Number: K182876 FDA UDI
FDA Product Code: FAJ FDA UDI
FBK FDA UDI
GMDN Term: Rigid optical cystoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 269 Millimeter FDA UDI

Category: Rigid optical cystoscope

Uro-N Cystoscope by UroViu Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical cystoscope.

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AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
IEC-Innoview GmbH — INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C. · Class II
AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: UroViu Corporation

Sources (1)

FDA UDI d85aa789-55ae-49b2-9f98-0e4dfd734ded 38 fields · synced May 30, 2026