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FDA 510(k)

Biodesign Otologic Repair Graft

K-Number: K161000 · 2016-05-11

ApplicantCook Biotech Incorporated
Decision Date2016-05-11
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Biodesign Otologic Repair Graft is a medical device manufactured by Cook Biotech Incorporated. It received FDA 510(k) clearance on 2016-05-11 under approval number K161000. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biodesign Otologic Repair Graft?

Biodesign Otologic Repair Graft is a medical device that received FDA 510(k) clearance on 2016-05-11. It is manufactured by Cook Biotech Incorporated. The 510(k) number is K161000.

When was Biodesign Otologic Repair Graft approved by the FDA?

Biodesign Otologic Repair Graft received FDA 510(k) clearance on 2016-05-11, under approval number K161000.

What company makes Biodesign Otologic Repair Graft?

Biodesign Otologic Repair Graft is manufactured by Cook Biotech Incorporated.

What is the FDA product code for Biodesign Otologic Repair Graft?

The FDA product code for Biodesign Otologic Repair Graft is KHJ.

Related Clinical Trials

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Other Devices by Cook Biotech Incorporated

K162741AxoGuard Nerve Connector K160136Flowable Wound Matrix K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft K162934Biodesign Parastomal Hernia Repair Graft K170016Biodesign Fistula Plug

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Related Devices (Code: KHJ)

K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech Incorporated

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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