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FDA 510(k)

Biodesign Fistula Plug

K-Number: K170016 · 2017-06-21

ApplicantCook Biotech Incorporated
Decision Date2017-06-21
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Biodesign Fistula Plug is a medical device manufactured by Cook Biotech Incorporated. It received FDA 510(k) clearance on 2017-06-21 under approval number K170016. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biodesign Fistula Plug?

Biodesign Fistula Plug is a medical device that received FDA 510(k) clearance on 2017-06-21. It is manufactured by Cook Biotech Incorporated. The 510(k) number is K170016.

When was Biodesign Fistula Plug approved by the FDA?

Biodesign Fistula Plug received FDA 510(k) clearance on 2017-06-21, under approval number K170016.

What company makes Biodesign Fistula Plug?

Biodesign Fistula Plug is manufactured by Cook Biotech Incorporated.

What is the FDA product code for Biodesign Fistula Plug?

The FDA product code for Biodesign Fistula Plug is FTM.

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

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Related Devices (Code: FTM)

K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited) K162554Gentrix Surgical MatrixAcell, Inc. K160181COLORADO THERAPEUTICS XENOGRAFT IMPLANTColorado Therapeutics, LLC K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)

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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