SAFIRA— 510(k) K230083

Substantially Equivalent

Medovate Limited

FDA 510(k) clearance K230083 for SAFIRA, Substantially Equivalent on 2023-10-31. Applicant: Medovate Limited.

Clearance details

Applicant: Medovate Limited
Product code: Code FRN
Advisory panel: General Hospital
Date received: 2023-01-11
Decision date: 2023-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Girton, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.