FDA.reportPublic FDA data

Urgent® PC Neuromodulation System

Primary DI
08717591240228
Brand
Urgent® PC Neuromodulation System
Company
Uroplasty, Inc.
Model
UPC 200
Catalog number
UPC 200
Device description
Stimulator
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NAMStimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAMStimulator, Peripheral Nerve, Non-Implanted, For Urinary IncontinenceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101847000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101847000URGENT PC STIMULATOR; URGENT PC LEAD SETUroplasty, Inc.2010-10-21NAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717591240228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717591240228087175912402288717591240228

GMDN Terms#

Term, Definition table
TermDefinition
Tibial nerve percutaneous incontinence-control electrical stimulation systemAn assembly of battery-powered devices designed to treat urinary and/or faecal incontinence with electrical stimuli applied to the sacral nerve via percutaneous tibial nerve stimulation (PTNS). It consists of a pair of electrodes, a needle electrode placed into a leg near the ankle and a surface electrode placed on the same leg, and a pulse generator. It produces an adjustable electrical pulse that travels to the sacral nerve plexus via the tibial nerve. It is operated by healthcare personnel who typically apply a predetermined series of treatment sessions to the patient.

Contacts#

Phone, Email table
PhoneEmail
866-258-2182info.usa@cogentixmedical.com

Regulatory Flags#

DUNS number
804002665
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717591240167Urgent® PC Neuromodulation SystemUPC 250UPC 2502016-09-19
08717591240266Macroplastique ImplantsMPQ-2.5MPQ-2.52014-06-20
08717591240273Rigid Endoscopic NeedleMRN-518MRN-5182016-09-22
08717591240280Rigid Endoscopic NeedleMRN-420MRN-4202016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850053656026VivallyAvation Medical, Inc.NAM2024-10-29
00850053656033VivallyAvation Medical, Inc.NAM2024-10-29
00860009634022VivallyAvation Medical, Inc.NAM2024-10-29
00860009634039VivallyAvation Medical, Inc.NAM2024-10-29
00860009634053VivallyAvation Medical, Inc.NAM2024-10-29
00860009634046VivallyAvation Medical, Inc.NAM2023-08-01
00860009634077VivallyAvation Medical, Inc.NAM2023-08-01
00860009634084VivallyAvation Medical, Inc.NAM2023-08-01
00860009634008VivallyAvation Medical, Inc.NAM2023-07-31
00860009634015VivallyAvation Medical, Inc.NAM2023-07-31
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