NAM
8 FDA 510(k) clearances · Product code
82 daysmedian time to decision
539 days90th percentile
8clearances measured
FDA profile
- Official device name
- Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5310
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2016: 26 · 2017: 52
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application (K220454) | Avation Medical, Inc. | 2023-04-03 |
| ZIDA Wearable Neuromodulation System (K192731) | Exodus Innovations | 2021-03-19 |
| NURO NEUROMODULATION SYSTEM (K132561) | Advanced Uro-Solutions, Inc. | 2013-11-05 |
| URGENT PC STIMULATOR; URGENT PC LEAD SET (K101847) | Uroplasty, Inc. | 2010-10-21 |
| URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 (K071822) | Uroplasty, Inc. | 2007-08-20 |
| URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 (K061333) | Uroplasty, Inc. | 2006-07-03 |
| URGENT PC NEUROMODULATION SYSTEM (K052025) | Uroplasty, Inc. | 2005-10-17 |
| UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE (DEN000002) | Urosurge, Inc. | 2000-02-09 |
Track NAM automatically
Every clearance here is in the API, with alerts when new ones post.