ArtiFascia— 510(k) K223445

Substantially Equivalent

Nurami Medical , Ltd.

FDA 510(k) clearance K223445 for ArtiFascia, Substantially Equivalent on 2023-08-10. Applicant: Nurami Medical , Ltd..

Clearance details

Applicant: Nurami Medical , Ltd.
Product code: Code GXQ
Advisory panel: Neurology
Date received: 2022-11-14
Decision date: 2023-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code GXQ

product code GXQ

Death: 11
Injury: 446
Other: 1
Total: 458

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.