Vibrant System
FDA 510(k) clearance K232830 · decided 2023-12-08
Clearance details
- K-number
- K232830
- Device name
- Vibrant System
- Applicant
- Vibrant, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-13
- Decision date
- 2023-12-08
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- QTN
- Device class
- 2
- Regulation number
- 876.5940
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Yokneam, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Vibrant System (K223031) | Vibrant, Ltd. | 2023-01-13 |
| Vibrant System (DEN210052) | Vibrant, Ltd. | 2022-08-26 |
Recalls involving this device
No recalls on record reference this clearance.