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FDA 510(k)

0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE

N.º K: K161996 · 2017-02-16

SolicitanteAmend Surgical, Inc.
Fecha de decisión2017-02-16
Código de productoMQV
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE is the device name listed in this FDA 510(k) record. The listed applicant is Amend Surgical, Inc.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K161996. 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 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE?

0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Amend Surgical, Inc.. The 510(k) number is K161996.

When did 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE receive FDA 510(k) clearance?

0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE received FDA 510(k) clearance on 2017-02-16, under 510(k) number K161996.

Who is the listed applicant for 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE?

The FDA 510(k) record lists Amend Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE?

The FDA product code for 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE is MQV.

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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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