SuperBall-RC— 510(k) K244015

Name: FDA 510(k) clearance K244015
Creator: U.S. Food and Drug Administration
Published: 2025-02-19

Substantially Equivalent

Arcuro Medical , Ltd.

FDA 510(k) clearance K244015 for SuperBall-RC, Substantially Equivalent on 2025-02-19. Applicant: Arcuro Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Arcuro Medical , Ltd.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
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 ↗

Recent devices under product code MBI

view all

K253065 — Aevumed SUPERCYNCH Button System2026-09-02
K262809 — ArthroTAK Tendon Anchor Kit2026-09-02
K262677 — Iconix Knotless T2026-08-27
K262047 — Grappler Suture Anchor System2026-08-03
K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down2026-07-30

More clearances from Arcuro Medical , Ltd.

view all

K223500 — SuperBall Meniscal Repair System2023-08-10
K180191 — SuperBall Meniscal Repair System2018-06-05

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.