Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
The Non-Implanted Peripheral Nerve Stimulator for Urinary Incontinence is a device that delivers electrical stimulation to peripheral nerves, such as the posterior tibial nerve, through external electrodes to modulate bladder function and reduce symptoms of urinary incontinence. It is used as a non-surgical neuromodulation therapy. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 876.5310 (Gastroenterology and Urology specialty).
Basic Information
- Product Code
- NAM
- Device Class
- FDA class 2
- Regulation Number
- 876.5310
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K220454 | Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application | Apr 03, 2023 | Substantially Equivalent | Avation Medical, Inc. |
| K192731 | ZIDA Wearable Neuromodulation System | Mar 19, 2021 | Substantially Equivalent | Exodus Innovations |
| K132561 | NURO NEUROMODULATION SYSTEM | Nov 05, 2013 | Substantially Equivalent | ADVANCED URO-SOLUTIONS, INC. |
| K101847 | URGENT PC STIMULATOR; URGENT PC LEAD SET | Oct 21, 2010 | Substantially Equivalent | UROPLASTY, INC. |
| K071822 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 | Aug 20, 2007 | Substantially Equivalent | UROPLASTY, INC. |
| K061333 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 | Jul 03, 2006 | Substantially Equivalent | UROPLASTY, INC. |
| K052025 | URGENT PC NEUROMODULATION SYSTEM | Oct 17, 2005 | Substantially Equivalent | UROPLASTY, INC. |
| DEN000002 | UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE | Feb 09, 2000 | Unknown | UROSURGE, INC. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.