FDA.reportPublic FDA data

De Novo DEN170049

Device
Innovo
Contact
anne-marie keenan
De Novo number
DEN170049
Product code
QAJ
Regulation
876.5330
Classification name
cutaneous electrode stimulator for urinary incontinence
Decision
granted (DENG)
Decision date
2018-11-06
Date received
2017-09-18
Classification advisory
Gastroenterology/Urology
Review advisory
Gastroenterology/Urology
Type
Direct

Current FDA Classification#

Product code
QAJ
Device name
Cutaneous Electrode Stimulator For Urinary Incontinence
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation
876.5330
Implant
N
Life sustain/support
N