NURO NEUROMODULATION SYSTEM

Stimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction

ADVANCED URO-SOLUTIONS, INC.

The following data is part of a premarket notification filed by Advanced Uro-solutions, Inc. with the FDA for Nuro Neuromodulation System.

Pre-market Notification Details

Device IDK132561
510k NumberK132561
Device Name:NURO NEUROMODULATION SYSTEM
ClassificationStimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction
Applicant ADVANCED URO-SOLUTIONS, INC. 717 LAKEGLEN DRIVE Suwanee,  GA  30024
ContactPenny Northcutt
CorrespondentPenny Northcutt
ADVANCED URO-SOLUTIONS, INC. 717 LAKEGLEN DRIVE Suwanee,  GA  30024
Product CodeNAM  
CFR Regulation Number876.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-15
Decision Date2013-11-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169654631 K132561 000
00643169654624 K132561 000
00763000157487 K132561 000

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