FDA 510(k)

Nisus Touch Negative Pressure Wound Therapy Pump

Номер K: K203693 · 2021-08-13

Дата решения2021-08-13

Код продуктаOMP

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Nisus Touch Negative Pressure Wound Therapy Pump is the device name listed in this FDA 510(k) record. The listed applicant is Cork Medical Products, LLC. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K203693. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Nisus Touch Negative Pressure Wound Therapy Pump?

Nisus Touch Negative Pressure Wound Therapy Pump is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Cork Medical Products, LLC. The 510(k) number is K203693.

When did Nisus Touch Negative Pressure Wound Therapy Pump receive FDA 510(k) clearance?

Nisus Touch Negative Pressure Wound Therapy Pump received FDA 510(k) clearance on 2021-08-13, under 510(k) number K203693.

Who is the listed applicant for Nisus Touch Negative Pressure Wound Therapy Pump?

The FDA 510(k) record lists Cork Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nisus Touch Negative Pressure Wound Therapy Pump?

The FDA product code for Nisus Touch Negative Pressure Wound Therapy Pump is OMP.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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.

Официальный источник

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