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FDA 510(k)

SuperBall Meniscal Repair System

K-Number: K223500 · 2023-08-10

ApplicantArcuro Medical , Ltd.
Decision Date2023-08-10
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SuperBall Meniscal Repair System is a medical device manufactured by Arcuro Medical , Ltd.. It received FDA 510(k) clearance on 2023-08-10 under approval number K223500. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SuperBall Meniscal Repair System?

SuperBall Meniscal Repair System is a medical device that received FDA 510(k) clearance on 2023-08-10. It is manufactured by Arcuro Medical , Ltd.. The 510(k) number is K223500.

When was SuperBall Meniscal Repair System approved by the FDA?

SuperBall Meniscal Repair System received FDA 510(k) clearance on 2023-08-10, under approval number K223500.

What company makes SuperBall Meniscal Repair System?

SuperBall Meniscal Repair System is manufactured by Arcuro Medical , Ltd..

What is the FDA product code for SuperBall Meniscal Repair System?

The FDA product code for SuperBall Meniscal Repair System is GAT.

Related Clinical Trials

NCT04097145 Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT04503395 ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES RECRUITING NCT03298477 EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study COMPLETED NCT06658730 Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance RECRUITING NCT03382457 Clinical Study of Edwards Cardioband FIT Valve Repair System ACTIVE_NOT_RECRUITING

Other Devices by Arcuro Medical , Ltd.

K180191SuperBall Meniscal Repair System K244015SuperBall-RC™

Related Devices (Code: GAT)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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