Cary— 510(k) K251111

Substantially Equivalent

Excitus AS

FDA 510(k) clearance K251111 for Cary, Substantially Equivalent on 2025-05-07. Applicant: Excitus AS.

Clearance details

Applicant: Excitus AS
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 2025-04-11
Decision date: 2025-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stavanger, NO

Download summary PDF View on FDA.gov ↗

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.