FDA 510(k)

Device 300423 Granules

Número K: K251556 · 2025-07-17

Data da decisão2025-07-17

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Device 300423 Granules 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 2025-07-17 under 510(k) number K251556. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Device 300423 Granules?

Device 300423 Granules is a medical device that received FDA 510(k) clearance on 2025-07-17. The listed applicant is Geistlich Pharma AG. The 510(k) number is K251556.

When did Device 300423 Granules receive FDA 510(k) clearance?

Device 300423 Granules received FDA 510(k) clearance on 2025-07-17, under 510(k) number K251556.

Who is the listed applicant for Device 300423 Granules?

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 300423 Granules?

The FDA product code for Device 300423 Granules is MQV.

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Outros registros que listam Geistlich Pharma AG como candidato(a)

K260364Device 300419 Strip 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; Geistlich Combi-Kit Colágeno®; Geistlich Perio-System Combi Pack K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®

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Fonte oficial

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