NAM — Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence Class II
FDA product code NAM covers "Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence", a Class II medical device regulated under 21 CFR 876.5310. Submissions are reviewed by the Gastroenterology, Urology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NAM
- Device Class
- Class II
- Regulation Number
- 876.5310
- Submission Type
- 510(k)
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220454 | Avation Medical | Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile… | Apr 3, 2023 |
| K192731 | Exodus Innovations | ZIDA Wearable Neuromodulation System | Mar 19, 2021 |
| K132561 | Advanced Uro-Solutions | NURO NEUROMODULATION SYSTEM | Nov 5, 2013 |
| K101847 | Uroplasty | URGENT PC STIMULATOR; URGENT PC LEAD SET | Oct 21, 2010 |
| K071822 | Uroplasty | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 | Aug 20, 2007 |
| K061333 | Uroplasty | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 | Jul 3, 2006 |
| K052025 | Uroplasty | URGENT PC NEUROMODULATION SYSTEM | Oct 17, 2005 |
| DEN000002 | Urosurge | UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE | Feb 9, 2000 |