510(k) K252391
K252391 is an FDA 510(k) premarket notification submitted by Bluewind Medical , Ltd. for the device "Revi System". The FDA issued a decision of Substantially Equivalent on Dec 12, 2025. The device falls under product code QXM (Implanted Tibial Electrical Urinary Continence Device), a Class II device regulated under 21 CFR 876.5305. Bluewind Medical , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 12, 2025
- Date Received
- Jul 31, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implanted Tibial Electrical Urinary Continence Device
- Device Class
- Class II
- Regulation Number
- 876.5305
- Review Panel
- GU
- Submission Type
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.