Product code NAM— Gastroenterology, Urology
NURO NEUROMODULATION SYSTEM
- Classification name
- Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
- Device class
- Class 2
- Regulation
- 21 CFR 876.5310
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code NAM
FDA has cleared devices under product code NAM between 2000 and 2023, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2021
- 2013
- 2010
- 2007
- 2006
- 2005
- 2000
Top applicants under product code NAM
Adverse events under product code NAM
product code NAM- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code NAM
- K220454 — Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
- K192731 — ZIDA Wearable Neuromodulation System
- K132561 — NURO NEUROMODULATION SYSTEM
- K101847 — URGENT PC STIMULATOR; URGENT PC LEAD SET
- K071822 — URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
- K061333 — URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12
- K052025 — URGENT PC NEUROMODULATION SYSTEM
- DEN000002 — UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.