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FDA 510(k)

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft

N.º K: K191696 · 2019-12-27

SolicitanteCook Biotech Incorporated
Fecha de decisión2019-12-27
Código de productoOXN
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue 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 2019-12-27 under 510(k) number K191696. The device is classified under product code OXN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft?

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft is a medical device that received FDA 510(k) clearance on 2019-12-27. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K191696.

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

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft received FDA 510(k) clearance on 2019-12-27, under 510(k) number K191696.

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

The FDA product code for Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft is OXN.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Cook Biotech Incorporated como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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 ReinforcementK171817Biodesign Diaphragmatic Hernia GraftK162934Biodesign Parastomal Hernia Repair GraftK170016Biodesign Fistula PlugK170945Biodesign Staple Line Reinforcement

Ver todos los 13 dispositivos →

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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