K233056

Substantially Equivalent

EpiZact

Applicant: Guidestar Medical Devices
Product code: FMF
Advisory panel: General Hospital
Date received: 2023-09-25
Decision date: 2023-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Victoria, CA

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.