510(k) K221918— ReFlow System Mini

Substantially Equivalent

Anuncia Medical, Inc.

Clearance details

Applicant: Anuncia Medical, Inc.
Product code: Code JXG
Advisory panel: Neurology
Date received: 2022-07-01
Decision date: 2022-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

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.