NAM · Class II · 21 CFR 876.5310

FDA Product Code NAM: Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence

Leading manufacturers include Uroplasty, Inc., Urosurge, Inc. and Advanced Uro-Solutions, 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
1–8 of 8
Cleared Apr 03, 2023
Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
K220454
Avation Medical, Inc.
Gastroenterology & Urology · 410d
Cleared Mar 19, 2021
ZIDA Wearable Neuromodulation System
K192731
Exodus Innovations
Gastroenterology & Urology · 539d
Cleared Nov 05, 2013
NURO NEUROMODULATION SYSTEM
K132561
Advanced Uro-Solutions, Inc.
Gastroenterology & Urology · 82d
Cleared Oct 21, 2010
URGENT PC STIMULATOR
K101847
Uroplasty, Inc.
Gastroenterology & Urology · 112d
Cleared Aug 20, 2007
URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
K071822
Uroplasty, Inc.
Gastroenterology & Urology · 48d
Cleared Jul 03, 2006
URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12
K061333
Uroplasty, Inc.
Gastroenterology & Urology · 52d
Cleared Oct 17, 2005
URGENT PC NEUROMODULATION SYSTEM
K052025
Uroplasty, Inc.
Gastroenterology & Urology · 82d
Not Cleared Feb 09, 2000
UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE
DEN000002
Urosurge, Inc.
Gastroenterology & Urology · 13d

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.