Vibrant System
FDA 510(k) clearance DEN210052 · decided 2022-08-26
Clearance details
- K-number
- DEN210052
- Device name
- Vibrant System
- Applicant
- Vibrant, Ltd.
- Decision
- Unknown
- Date received
- 2021-11-30
- Decision date
- 2022-08-26
- Days to decision
- 269 days
- Clearance type
- Direct
- 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
+ Add to Predicate Builder ◉ Watch Vibrant
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Vibrant System (K232830) | Vibrant, Ltd. | 2023-12-08 |
| Vibrant System (K223031) | Vibrant, Ltd. | 2023-01-13 |
Recalls involving this device
No recalls on record reference this clearance.