Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence
Gastroenterology, Urology · 21 CFR 876.5310
Recent MDR events
92 adverse event reports on file
- ZIDA WEARABLE NEUROMODULATION SYSTEMFeb 8, 2026InjuryExodus Innovations Ltd.3021630651-2006-00001
- ZIDA WEARABLE NEUROMODULATION SYSTEMFeb 7, 2026InjuryExodus Innovations Ltd.3021071-2026-00001
- STIMGUARD INCONTINENCE STIMULATORAug 12, 2023InjuryStimguardMW5130928
- URGENT PCAug 12, 2023InjuryUroplastyMW5142713
- PERCUTANEOUS TIBIAL NEUROMODULATIONJul 17, 2023OtherUnkMW5119573
- URGENT PC NEUROMODULATION SYSTEM LEAD SETSep 13, 2021MalfunctionLaborie Medical TechnologiesMW5103878
- URGENT PC NEUROMODULATION SYSTEMApr 8, 2021InjuryUroplasty, Llc3002647932-2021-00003
- NURODec 30, 2019InjuryMedtronic Neuromodulation3007566237-2019-02625
- NUROSep 4, 2019InjuryMedtronic Neuromodulation3007566237-2019-01887
- NUROSep 14, 2018InjuryMedtronic Neuromodulation3007566237-2018-02750
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code
Uroplasty, Llc
Minnetonka, MN, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Quality Tech Services, Llc
Bloomington, MN, US
Cardinal Health
Wabasha, MN, US
Medtronic Neuromodulation
Minneapolis, MN, US
Exodus Innovations
Sufa Southern, IL
Avation Medical
Columbus, OH, US
Nortech Systems, Inc.
Milaca, MN, US
510(k) clearances
8 clearances for this product code
- Avation Medical, Inc.Apr 3, 2023
K220454 · Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
- Exodus InnovationsMar 19, 2021
K192731 · ZIDA Wearable Neuromodulation System
- Advanced Uro-Solutions, Inc.Nov 5, 2013
K132561 · NURO NEUROMODULATION SYSTEM
- Uroplasty, Inc.Oct 21, 2010
K101847 · URGENT PC STIMULATOR; URGENT PC LEAD SET
- Uroplasty, Inc.Aug 20, 2007
K071822 · URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
- Uroplasty, Inc.Jul 3, 2006
K061333 · URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12
- Uroplasty, Inc.Oct 17, 2005
K052025 · URGENT PC NEUROMODULATION SYSTEM
- Urosurge, Inc.Feb 9, 2000
DEN000002 · UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE