510(k) K253651
- Device
- Revi System
- Applicant
- Bluewind Medical , Ltd.
- 510(k) number
- K253651
- Product code
- QXM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-28
- Date received
- 2025-11-20
- Regulation
- 876.5305
- Classification name
- Implanted Tibial Electrical Urinary Continence Device
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Angel Estrada
- Address
- 6 Maskit St. Herzliya IL 4614002 4614002
FDA Registration Numbers#
- 3011606051
- 3012239564
- 3003923762
- 3008729892
- 3038988751