FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Revi System
K Number: K252391
·
Decision Dec 12, 2025
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
2
Applicant Total
3
Review Days
134
Basic Information
- Device Name
- Revi System
- K Number
- K252391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5305
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bluewind Medical , Ltd.
- Date Received
- July 31, 2025
- Decision Date
- December 12, 2025
- Product Code
- QXM
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QXM | Implanted Tibial Electrical Urinary Continence Device | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QXM), ordered by most recent decision date.
Revi System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Revi System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology