FDA product code NAM: Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
NAM is the FDA product code for stimulator, peripheral nerve, non-implanted, for urinary incontinence. It is a Class II device, regulated under 21 CFR 876.5310 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 7 510(k) submissions under NAM, 1 in the last five years, from 4 different applicants. The average 510(k) review took 189 days (median 82). 1 De Novo request was granted under it.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence |
| Device class | Class II |
| Regulation | 21 CFR 876.5310 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for NAM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 539 |
| 2023 | 1 | 410 |
Compare with all 510(k) review times · Search every NAM clearance
Top NAM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Uroplasty, Inc. | 4 | 2010-10-21 |
| Avation Medical, Inc. | 1 | 2023-04-03 |
| Exodus Innovations | 1 | 2021-03-19 |
| Advanced Uro-Solutions, Inc. | 1 | 2013-11-05 |
Most recent NAM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220454 | Avation Medical, Inc. | Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application | 2023-04-03 | 410 |
| K192731 | Exodus Innovations | ZIDA Wearable Neuromodulation System | 2021-03-19 | 539 |
| K132561 | Advanced Uro-Solutions, Inc. | NURO NEUROMODULATION SYSTEM | 2013-11-05 | 82 |
| K101847 | Uroplasty, Inc. | URGENT PC STIMULATOR; URGENT PC LEAD SET | 2010-10-21 | 112 |
| K071822 | Uroplasty, Inc. | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 | 2007-08-20 | 48 |
Recalls for NAM devices
openFDA lists no recalls for product code NAM.
Frequently asked questions
What is FDA product code NAM?
NAM is the FDA product code for stimulator, peripheral nerve, non-implanted, for urinary incontinence. It is a Class II device, regulated under 21 CFR 876.5310 and reviewed by the Gastroenterology and Urology panel.
What device class is NAM?
Class II, regulation 21 CFR 876.5310. Typical premarket route: 510(k).
How long does a 510(k) take for product code NAM?
Across 7 cleared submissions the average was 189 days from receipt to decision (median 82).
Which companies have the most NAM clearances?
Uroplasty, Inc. (4); Avation Medical, Inc. (1); Exodus Innovations (1); Advanced Uro-Solutions, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NAM
- Run a recall and safety report across every NAM manufacturer
- Watch product code NAM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times