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FDA 510(k)

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver

N.º K: K230015 · 2023-06-16

SolicitanteLaurane Medical Sas
Fecha de decisión2023-06-16
Código de productoKNW
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver is the device name listed in this FDA 510(k) record. The listed applicant is Laurane Medical Sas. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K230015. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver?

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Laurane Medical Sas. The 510(k) number is K230015.

When did OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver receive FDA 510(k) clearance?

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver received FDA 510(k) clearance on 2023-06-16, under 510(k) number K230015.

Who is the listed applicant for OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver?

The FDA 510(k) record lists Laurane Medical Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver?

The FDA product code for OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver is KNW.

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Dispositivos relacionados (Código: KNW)

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.

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Fuente oficial

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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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