FDA 510(k)

ConvaVAC™ Negative Pressure Wound Therapy System

Номер K: K253263 · 2026-06-24

Дата решения2026-06-24

Код продуктаOMP

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

ConvaVAC™ Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited, Gdc Building. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K253263. 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 ConvaVAC™ Negative Pressure Wound Therapy System?

ConvaVAC™ Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Convatec Limited, Gdc Building. The 510(k) number is K253263.

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

ConvaVAC™ Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2026-06-24, under 510(k) number K253263.

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

The FDA 510(k) record lists Convatec Limited, Gdc Building as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ConvaVAC™ Negative Pressure Wound Therapy System?

The FDA product code for ConvaVAC™ Negative Pressure Wound Therapy System 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.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.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.

Официальный источник

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