Biodesign Staple Line Reinforcement
K-Number: K201000 · 2020-07-13
ApplicantCook Biotech Incorporated
Decision Date2020-07-13
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Biodesign Staple Line Reinforcement is a medical device manufactured by Cook Biotech Incorporated. It received FDA 510(k) clearance on 2020-07-13 under approval number K201000. 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 Staple Line Reinforcement?
Biodesign Staple Line Reinforcement is a medical device that received FDA 510(k) clearance on 2020-07-13. It is manufactured by Cook Biotech Incorporated. The 510(k) number is K201000.
When was Biodesign Staple Line Reinforcement approved by the FDA?
Biodesign Staple Line Reinforcement received FDA 510(k) clearance on 2020-07-13, under approval number K201000.
What company makes Biodesign Staple Line Reinforcement?
Biodesign Staple Line Reinforcement is manufactured by Cook Biotech Incorporated.
What is the FDA product code for Biodesign Staple Line Reinforcement?
The FDA product code for Biodesign Staple Line Reinforcement is FTM.
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Other Devices by Cook Biotech Incorporated
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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
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.