FDA 510(k)

Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug

Número K: K161221 · 2016-05-26

Data da decisão2016-05-26

Código do produtoFTM

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech Incorporated. It received FDA 510(k) clearance on 2016-05-26 under 510(k) number K161221. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K161221.

When did Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug receive FDA 510(k) clearance?

Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug received FDA 510(k) clearance on 2016-05-26, under 510(k) number K161221.

Who is the listed applicant for Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug?

The FDA 510(k) record lists Cook Biotech Incorporated as the applicant. This does not by itself establish the device manufacturer.

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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Outros registros que listam Cook Biotech Incorporated como candidato(a)

K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)K201000Biodesign Staple Line Reinforcement K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft K171817Biodesign Diaphragmatic Hernia Graft K162934Biodesign Parastomal Hernia Repair Graft K170016Biodesign Fistula Plug

Ver todos os 13 dispositivos →

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Fonte oficial

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