K230849
- 510(k) number
- K230849
- Device name
- ELLAVI UBT
- Applicant
- Sinapi Biomedical (Pty) , Ltd. ZA
- Product code
- OQY — Intrauterine Tamponade Balloon
- Decision date
- 2023-11-13
- Date received
- 2023-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K230849.pdf
Official FDA record: K230849
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.