K232830
- 510(k) number
- K232830
- Device name
- Vibrant System
- Applicant
- Vibrant, Ltd. IL
- Product code
- QTN — Orally Ingested Transient Device For Constipation
- Decision date
- 2023-12-08
- Date received
- 2023-09-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232830.pdf
Official FDA record: K232830
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.