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FDA 510(k)

SuperBall Meniscal Repair System

K-Number: K180191 · 2018-06-05

ApplicantArcuro Medical , Ltd.
Decision Date2018-06-05
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SuperBall Meniscal Repair System is the device name listed in this FDA 510(k) record. The listed applicant is Arcuro Medical , Ltd.. It received FDA 510(k) clearance on 2018-06-05 under 510(k) number K180191. 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 2018-06-05. The listed applicant is Arcuro Medical , Ltd.. The 510(k) number is K180191.

When did SuperBall Meniscal Repair System receive FDA 510(k) clearance?

SuperBall Meniscal Repair System received FDA 510(k) clearance on 2018-06-05, under 510(k) number K180191.

Who is the listed applicant for SuperBall Meniscal Repair System?

The FDA 510(k) record lists Arcuro Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Arcuro Medical , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K244015SuperBall-RC™K223500SuperBall Meniscal Repair System

Related Devices (Code: GAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.K253024ProZip Knotless ImplantRiverpoint Medical

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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