K240037 is an FDA 510(k) clearance 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 Cleared decision on May 2, 2024, 118 days after receiving the submission on January 5, 2024.
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 | K240037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2024 |
| Decision Date | May 02, 2024 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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. |