FDA 510(k)

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft

N.º K: K160869 · 2016-04-29

Fecha de decisión2016-04-29

Código de productoFTM

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft 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 2016-04-29 under 510(k) number K160869. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft?

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K160869.

When did Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft receive FDA 510(k) clearance?

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft received FDA 510(k) clearance on 2016-04-29, under 510(k) number K160869.

Who is the listed applicant for Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft?

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 Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft?

The FDA product code for Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft is FTM.

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Otros registros que enlistan a Cook Biotech Incorporated como solicitante

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

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Fuente oficial

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