FDA 510(k)

UNO Negative Pressure Wound Therapy System

N.º K: K161599 · 2017-04-06

SolicitanteGenadyne Biotechnologies, Inc.

Fecha de decisión2017-04-06

Código de productoOMP

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

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 2017-04-06 under 510(k) number K161599. 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 UNO Negative Pressure Wound Therapy System?

UNO Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Genadyne Biotechnologies, Inc.. The 510(k) number is K161599.

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

UNO Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2017-04-06, under 510(k) number K161599.

Who is the listed applicant for 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 UNO Negative Pressure Wound Therapy System?

The FDA product code for 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 K210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System

Ver todos los 8 dispositivos →

Dispositivos relacionados (Código: OMP)

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.

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.