Product code NAM
- Device name
- Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5310
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220454 | Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application | Avation Medical, Inc. | 2023-04-03 |
| K192731 | ZIDA Wearable Neuromodulation System | Exodus Innovations | 2021-03-19 |
| K132561 | NURO NEUROMODULATION SYSTEM | Advanced Uro-Solutions, Inc. | 2013-11-05 |
| K101847 | URGENT PC STIMULATOR; URGENT PC LEAD SET | Uroplasty, Inc. | 2010-10-21 |
| K071822 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 | Uroplasty, Inc. | 2007-08-20 |
| K061333 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 | Uroplasty, Inc. | 2006-07-03 |
| K052025 | URGENT PC NEUROMODULATION SYSTEM | Uroplasty, Inc. | 2005-10-17 |
| DEN000002 | UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE | Urosurge, Inc. | 2000-02-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850053656026 | Vivally | Avation Medical, Inc. | 2024-10-29 |
| 00850053656033 | Vivally | Avation Medical, Inc. | 2024-10-29 |
| 00860009634022 | Vivally | Avation Medical, Inc. | 2024-10-29 |
| 00860009634039 | Vivally | Avation Medical, Inc. | 2024-10-29 |
| 00860009634053 | Vivally | Avation Medical, Inc. | 2024-10-29 |
| 00860009634046 | Vivally | Avation Medical, Inc. | 2023-08-01 |
| 00860009634077 | Vivally | Avation Medical, Inc. | 2023-08-01 |
| 00860009634084 | Vivally | Avation Medical, Inc. | 2023-08-01 |
| 00860009634008 | Vivally | Avation Medical, Inc. | 2023-07-31 |
| 00860009634015 | Vivally | Avation Medical, Inc. | 2023-07-31 |
| 07297539076115 | Zida | EXODUS INNOVATION LTD | 2022-05-05 |
| 07297539075125 | Zida | EXODUS INNOVATION LTD | 2022-05-05 |
| 07297539074135 | Zida | EXODUS INNOVATION LTD | 2022-05-05 |
| 07297539073145 | Zida | EXODUS INNOVATION LTD | 2022-05-05 |
| 07297539072155 | Zida | EXODUS INNOVATION LTD | 2022-05-05 |
| 07297539070175 | Zida | EXODUS INNOVATION LTD | 2022-05-05 |
| 07297539014728 | Zida | EXODUS INNOVATION LTD | 2022-05-05 |
| 07297539077105 | Zida | EXODUS INNOVATION LTD | 2022-05-05 |
| 07297539071165 | Zida | EXODUS INNOVATION LTD | 2022-05-04 |
| 07297539085124 | Zida | EXODUS INNOVATION LTD | 2022-03-04 |
| 07297539008512 | Zida | EXODUS INNOVATION LTD | 2022-03-04 |
| 07297539080174 | Zida | EXODUS INNOVATION LTD | 2022-03-03 |
| 07297539081164 | Zida | EXODUS INNOVATION LTD | 2022-03-03 |
| 07297539082154 | Zida | EXODUS INNOVATION LTD | 2022-03-03 |
| 07297539083144 | Zida | EXODUS INNOVATION LTD | 2022-03-03 |
| 07297539084134 | Zida | EXODUS INNOVATION LTD | 2022-03-03 |
| 07297539086114 | Zida | EXODUS INNOVATION LTD | 2022-03-03 |
| 07297539087104 | Zida | EXODUS INNOVATION LTD | 2022-03-03 |
| 08717591240228 | Urgent® PC Neuromodulation System | Uroplasty, Inc. | 2016-09-19 |
| 08717591240167 | Urgent® PC Neuromodulation System | Uroplasty, Inc. | 2016-09-19 |