FDA Product Code NAM: Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence
Leading manufacturers include Exodus Innovations and Avation Medical, Inc..
8
Total
7
Cleared
167d
Avg days
2000
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence Devices (Product Code NAM)
8 devices
Cleared
Apr 03, 2023
Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
Avation Medical, Inc.
Gastroenterology & Urology
410d
Cleared
Mar 19, 2021
ZIDA Wearable Neuromodulation System
Exodus Innovations
Gastroenterology & Urology
539d
About Product Code NAM - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code NAM since 2000, with 7 receiving FDA clearance (average review time: 167 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
NAM devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →