DEN220073 is an FDA 510(k) submission for the Revi System. This device is classified as a Implanted Tibial Electrical Urinary Continence Device (Class II - Special Controls, product code QXM).
Submitted by Bluewind Medical , Ltd. (Herzliya, IL). The FDA issued a Not Cleared (DENG) decision on August 16, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5305. An Implanted Tibial Electrical Urinary Continence Device Is An Implanted Prescription Device That Receives Power From A Non-implanted External Power Source To Provide Electrical Stimulation Of The Tibial Nerve In Proximity To The Ankle. The Device Is Intended For The Treatment Of Overactive Bladder Related Symptoms Of Urge Urinary Incontinence, Urinary Urgency, Urinary Frequency And Nocturia..
| 510(k) Number | DEN220073 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | October 05, 2022 |
| Decision Date | August 16, 2023 |
| Days to Decision | 315 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | QXM - Implanted Tibial Electrical Urinary Continence Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5305 |
| Definition | An Implanted Tibial Electrical Urinary Continence Device Is An Implanted Prescription Device That Receives Power From A Non-implanted External Power Source To Provide Electrical Stimulation Of The Tibial Nerve In Proximity To The Ankle. The Device Is Intended For The Treatment Of Overactive Bladder Related Symptoms Of Urge Urinary Incontinence, Urinary Urgency, Urinary Frequency And Nocturia. |