FDA 510(k)

Device 300419 Strip

N.º K: K260364 · 2026-06-02

Fecha de decisión2026-06-02

Código de productoMQV

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Device 300419 Strip is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich Pharma AG. It received FDA 510(k) clearance on 2026-06-02 under 510(k) number K260364. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Device 300419 Strip?

Device 300419 Strip is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is Geistlich Pharma AG. The 510(k) number is K260364.

When did Device 300419 Strip receive FDA 510(k) clearance?

Device 300419 Strip received FDA 510(k) clearance on 2026-06-02, under 510(k) number K260364.

Who is the listed applicant for Device 300419 Strip?

The FDA 510(k) record lists Geistlich Pharma AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Device 300419 Strip?

The FDA product code for Device 300419 Strip is MQV.

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Otros registros que enlistan a Geistlich Pharma AG como solicitante

K260532Derma-Gide K251323Device 104 Particulate K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Comprimido; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Kit Combi Colágeno Geistlich; Paquete Combi Sistema Perio-Geistlich K251556Device 300423 Granules K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®

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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.