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FDA 510(k)

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft

K-Number: K191696 · 2019-12-27

ApplicantCook Biotech Incorporated
Decision Date2019-12-27
Product CodeOXN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft is a medical device manufactured by Cook Biotech Incorporated. It received FDA 510(k) clearance on 2019-12-27 under approval number K191696. The device is classified under product code OXN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft?

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft is a medical device that received FDA 510(k) clearance on 2019-12-27. It is manufactured by Cook Biotech Incorporated. The 510(k) number is K191696.

When was Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft approved by the FDA?

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft received FDA 510(k) clearance on 2019-12-27, under approval number K191696.

What company makes Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft?

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft is manufactured by Cook Biotech Incorporated.

What is the FDA product code for Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft?

The FDA product code for Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft is OXN.

Related Clinical Trials

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 41972695 Glycerol-Based Cryopreservation of CELT-Fat: Identification of the Optimal Concentration in a GMP-Compatible Protocol. Cells (2026) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025) PMID: 40223422 Cell-Free Biomimetic Tracheal Graft via Hybrid 3D Printing for Enhanced Tracheal Reconstruction. Advanced healthcare materials (2025)

Other Devices by Cook Biotech Incorporated

K162741AxoGuard Nerve Connector K160136Flowable Wound Matrix K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug K161000Biodesign Otologic Repair Graft K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft K162934Biodesign Parastomal Hernia Repair Graft

View all 13 devices →

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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