SuperBall-RC— 510(k) K244015

Substantially Equivalent

Arcuro Medical , Ltd.

FDA 510(k) clearance K244015 for SuperBall-RC, Substantially Equivalent on 2025-02-19. Applicant: Arcuro Medical , Ltd..

Clearance details

Applicant: Arcuro Medical , Ltd.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2024-12-26
Decision date: 2025-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Misgav, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.