Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
K-Number: K161221 · 2016-05-26
ApplicantCook Biotech Incorporated
Decision Date2016-05-26
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug is a medical device manufactured by Cook Biotech Incorporated. It received FDA 510(k) clearance on 2016-05-26 under approval number K161221. 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 Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug?
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug is a medical device that received FDA 510(k) clearance on 2016-05-26. It is manufactured by Cook Biotech Incorporated. The 510(k) number is K161221.
When was Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug approved by the FDA?
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug received FDA 510(k) clearance on 2016-05-26, under approval number K161221.
What company makes Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug?
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug is manufactured by Cook Biotech Incorporated.
What is the FDA product code for Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug?
The FDA product code for Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug is FTM.
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Other Devices by Cook Biotech Incorporated
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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.