FDA 510(k)

Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System

N.º K: K210107 · 2022-06-01

SolicitanteGenadyne Biotechnologies, Inc.

Fecha de decisión2022-06-01

Código de productoOMP

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Genadyne Biotechnologies, Inc.. It received FDA 510(k) clearance on 2022-06-01 under 510(k) number K210107. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System?

Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2022-06-01. The listed applicant is Genadyne Biotechnologies, Inc.. The 510(k) number is K210107.

When did Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2022-06-01, under 510(k) number K210107.

Who is the listed applicant for Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System?

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

What is the FDA product code for Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System?

The FDA product code for Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System is OMP.

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Otros registros que enlistan a Genadyne Biotechnologies, Inc. como solicitante

K253429Genadyne ASTRA NPWT K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)K233614Genadyne DUO NPWT K221888Genadyne Hybrid Foam Dressings K221891UNO Negative Pressure Wound Therapy System K180840UNO Negative Pressure Wound Therapy System

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Dispositivos relacionados (Código: OMP)

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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.