Panels › Gastroenterology, Urology › Product code NAM · Class 2
Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Regulation 876.5310
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NAM
| Company | 510(k)s | Recalls |
|---|---|---|
| Uroplasty, Inc. | 4 | 0 |
| Advanced Uro-Solutions, Inc. | 1 | 0 |
| Avation Medical, Inc. | 1 | 0 |
| Exodus Innovations | 1 | 0 |
| Urosurge, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 3, 2023 | K220454 | Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application Avation Medical, Inc. | NAM |
| Mar 19, 2021 | K192731 | ZIDA Wearable Neuromodulation System Exodus Innovations, IL | NAM |
| Nov 5, 2013 | K132561 | NURO NEUROMODULATION SYSTEM Advanced Uro-Solutions, Inc. | NAM |
| Oct 21, 2010 | K101847 | URGENT PC STIMULATOR; URGENT PC LEAD SET Uroplasty, Inc. | NAM |
| Aug 20, 2007 | K071822 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 Uroplasty, Inc. | NAM |
| Jul 3, 2006 | K061333 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 Uroplasty, Inc. | NAM |
| Oct 17, 2005 | K052025 | URGENT PC NEUROMODULATION SYSTEM Uroplasty, Inc. | NAM |
| Feb 9, 2000 | DEN000002 | UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE Urosurge, Inc. | NAM |
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