FDA Product Code
FDA Product Code NAM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5310
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220454 | Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application | Avation Medical, Inc. | 2023-04-03 | Traditional | PDF ↗ |
| K192731 | ZIDA Wearable Neuromodulation System | Exodus Innovations | 2021-03-19 | Traditional | PDF ↗ |
| K132561 | NURO NEUROMODULATION SYSTEM | Advanced Uro-Solutions, Inc. | 2013-11-05 | Traditional | PDF ↗ |
| K101847 | URGENT PC STIMULATOR; URGENT PC LEAD SET | Uroplasty, Inc. | 2010-10-21 | Traditional | PDF ↗ |
| K071822 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 | Uroplasty, Inc. | 2007-08-20 | Traditional | PDF ↗ |
| K061333 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 | Uroplasty, Inc. | 2006-07-03 | Special | PDF ↗ |
| K052025 | URGENT PC NEUROMODULATION SYSTEM | Uroplasty, Inc. | 2005-10-17 | Traditional | PDF ↗ |
| DEN000002 | UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE | Urosurge, Inc. | 2000-02-09 | Post-NSE | — |
Product code NAM · Class II · Gastroenterology, Urology. Data: openFDA.