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FDA 510(k)

ACTIVBRAID™

K-Number: K223822 · 2023-06-02

ApplicantEmbody, Inc.
Decision Date2023-06-02
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACTIVBRAID™ is the device name listed in this FDA 510(k) record. The listed applicant is Embody, Inc.. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K223822. 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 ACTIVBRAID™?

ACTIVBRAID™ is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Embody, Inc.. The 510(k) number is K223822.

When did ACTIVBRAID™ receive FDA 510(k) clearance?

ACTIVBRAID™ received FDA 510(k) clearance on 2023-06-02, under 510(k) number K223822.

Who is the listed applicant for ACTIVBRAID™?

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

What is the FDA product code for ACTIVBRAID™?

The FDA product code for ACTIVBRAID™ is GAT.

Other records listing Embody, Inc. 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.

K252647Tapestry Biointegrative ImplantK220867Tapestry Biointegrative ImplantK213958Bioabsorbable AnchorK212306Tapestry Biointegrative ImplantK201572TAPESTRY Biointegrative Implant

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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