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FDA 510(k)

Meniscus Versaflex

K-Number: K254188 · 2026-02-19

ApplicantGM Dos Reis Industria e Comercio Ltda.
Decision Date2026-02-19
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Meniscus Versaflex is the device name listed in this FDA 510(k) record. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K254188. 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 Meniscus Versaflex?

Meniscus Versaflex is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K254188.

When did Meniscus Versaflex receive FDA 510(k) clearance?

Meniscus Versaflex received FDA 510(k) clearance on 2026-02-19, under 510(k) number K254188.

Who is the listed applicant for Meniscus Versaflex?

The FDA 510(k) record lists GM Dos Reis Industria e Comercio Ltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Meniscus Versaflex?

The FDA product code for Meniscus Versaflex is GAT.

Other records listing GM Dos Reis Industria e Comercio Ltda. as applicant

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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, LLCK253145Pre-Sutured TendonRti Surgical, Inc.K253024ProZip Knotless ImplantRiverpoint MedicalK252225PowerKnot High Strength SuturesMedacta International S.A.

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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