FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Vibrant System
K Number: K232830
·
Decision Dec 8, 2023
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
3
Review Days
86
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Basic Information
- Device Name
- Vibrant System
- K Number
- K232830
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5940
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vibrant, Ltd.
- Date Received
- September 13, 2023
- Decision Date
- December 8, 2023
- Product Code
- QTN
- 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 |
|---|---|---|---|
| QTN | Orally Ingested Transient Device For Constipation | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QTN), ordered by most recent decision date.
Vibrant System
FDA 510(k)
FDA Class 2
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Vibrant System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology