FDA 510(k)

Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)

Número K: K232646 · 2024-05-24

Data da decisão2024-05-24

Código do produtoKHJ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) 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 2024-05-24 under 510(k) number K232646. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)?

Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K232646.

When did Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) receive FDA 510(k) clearance?

Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) received FDA 510(k) clearance on 2024-05-24, under 510(k) number K232646.

Who is the listed applicant for Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)?

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 Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)?

The FDA product code for Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) is KHJ.

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

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 K170945Biodesign Staple Line Reinforcement

Ver todos os 13 dispositivos →

Dispositivos Relacionados (Código: KHJ)

K260266Tympendi™ (810)Grace Medical, Inc.K161000Biodesign Otologic Repair GraftCook Biotech Incorporated

Fonte oficial

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