ELLAVI UBT— 510(k) K230849

Substantially Equivalent

Sinapi Biomedical (Pty) , Ltd.

FDA 510(k) clearance K230849 for ELLAVI UBT, Substantially Equivalent on 2023-11-13. Applicant: Sinapi Biomedical (Pty) , Ltd..

Clearance details

Applicant: Sinapi Biomedical (Pty) , Ltd.
Product code: Code OQY
Advisory panel: Obstetrics/Gynecology
Date received: 2023-03-28
Decision date: 2023-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stellenbosch, ZA

Download summary PDF View on FDA.gov ↗

Adverse events under product code OQY

product code OQY

Death: 8
Injury: 616
Malfunction: 500
Total: 1,124

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.